Career Opportunity: Specialist,Post Market Surveillance

Specialist,Post Market Surveillance

Perm – $70K – $80K – Depends on experience.

JOB SUMMARY:

Responsible for receiving, reviewing and processing all product inquiries for complaint evaluation as required by applicable regulations, standards, and company policy. This position requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211). Helps provide customer support and serve as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints. This role also partners with Quality Engineering on product investigations and trends.

ESSENTIAL/PRIMARY DUTIES:

  • Responsible for receiving, reviewing and processing all product inquiries for complaint evaluation as required by applicable regulations, standards, and company policy.
  • This position requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211). Helps provide customer support and serve as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints. This role also partners with Quality Engineering on product investigations and trends.

EDUCATION and/or EXPERIENCE:

  • Associates Degree preferred One (1) or more years’ quality assurance experience, or an equivalent combination of education and experience may be substituted
  • Requires strict attention to details, careful risk assessment, strong customer service, effective communication, and strong data entre.

Randstad Life Sciences

Four Parkway North, Suite 120

Deerfield, IL 60015

T 847.527.6107

C 815.721.5833

paul.zeman@randstadusa.com

lifesciences.randstadusa.com

Talent Acquisition | Outsourcing & FSP | Consulting | Direct Hire 

Follow Randstad Life Sciences on: LinkedIn, Twitter and Facebook

Connect with me on LinkedIn: https://www.linkedin.com/in/pzeman2

Quality Engineer opening at Ameda, Inc.

Ameda, Inc.

485 E Half Day Rd., Suite 320

Buffalo Grove, IL 60089

HR Manager: Lois Lloyd. 847-964-2627

Job Title:  Quality Engineer – Supplier Management

We are seeking an experienced, high caliber, Quality Engineer – Supplier Management responsible as the key liaison between operations, engineering, quality, suppliers and the customer.  This position is responsible to ensure the overall specifications, processes, quality/regulatory requirements and expectations are met for all purchased product.

 

Responsibilities:

  • Responsible for ensuring that the supplier quality management system is compliant with FDA regulations and ISO 13485.
  • Writing/updating procedures as required to ensure the supplier quality management system is compliant with FDA regulations and ISO 13485.
  • Responsible to ensure product qualification (IQ/OQ/PQ) and evaluation activities resulting in acceptable and consistent supply.
  • Ability to perform supplier quality audits and track findings to closure.
  • Responsible for leading, monitoring, and tracking to closure the supplier corrective action process.
  • Facilitate reporting and notifying suppliers of cost-recovery requirements resulting from the need to contain, segregate or handle non-conforming parts.
  • Complaint investigation
  • Travel required up to 20%.

 

Required Knowledge, Skills and Abilities:

  • Medical device experience required.
  • Contract Manufacturing / Manufacturing Plant experience required
  • Bachelor’s Degree in Engineering, or equivalent quality engineering work experience (5 to 8 years).
  • Experience in medical device manufacturing operations.
  • Validation experience.
  • Regulatory cGMP, QSR and ISO knowledge base as related to the medical device industry.
  • SCAR and/or CAPA experience.
  • Excellent English verbal and written communication skills.
  • Project management skills.
  • Proficient in Microsoft Office Suite (emphasis on Excel), Internet based tracking systems
  • Auditor Certification and experience is required.
  • Knowledge of Ethylene Oxide and Gamma Irradiation Sterility Assurance validation and maintenance is desired.
  • ASQ Certification a plus.

 

Required Behavioral Competencies

  • Quality Orientation – Accomplishes tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checks processes and tasks; is watchful over a period of time.
  • Builds Strategic Working Relationships – Develops and uses collaborative relationships to facilitate the accomplishment of work goals.
  • Facilitates Change – Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace.
  • Manages Work – Effectively manages one’s time and resources to ensure that work is completed efficiently.
  • Decision Making – Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
  • Initiates Action – Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
  • Contributes to Team Success – Actively participates as a member of a team to move the team toward the completion of goals.

Invitation from ASQ Chicago Section


Click Here to Register Online

When:  

Wednesday, May 11th, 2016

Doors Open at 5:30 PM

Registration & Check-in: 5:30 PM

Networking: 6:00 – 6:15 PM

Pre-Dinner Session: 6:15 – 7:00 PM

Dinner Starts 7:00 PM
Post Dinner Session: ~ 8.00p

Adjourn: ~ 9.00pm

Where

Pescatore Palace, 3400 N. River Road, Franklin Park, Illinois 60631

What:

Menu – Focaccio Bruschetta
                Mostaccolay/Marianna sauce

                Salad/dressing

                Chicken Breast Vesuvius

                Beef Medallion

                Roast Potatoes

                Green Beans

                Ice Cream

       Coffee/Soda
Pre-dinner Synopsis- FDA Inspections and “GO” 101
Speaker – Karen Masley-Joseph 

Presentation:

Synopsis: This presentation will provide an overview of FDA’s Office of Global Regulatory Operations and Policy (GO) and FDA’s interaction with industry through inspections. It will describe how GO operations impact you as a consumer and provide some helpful references for when and how FDA interacts with the industries it regulates.

Presenter: Karen Masley-Joseph is a Case Review Expert in the Office of Regulatory Affairs (ORA) at the Food and Drug Administration (FDA). In this role, Karen leads enterprise-wide improvements of FDA compliance processes and provides consults to the Department of Justice on enforcement actions of medical devices, pharmaceuticals and dietary supplements. In her 14 years at FDA, Karen has held many positions including the Director of the ORA Quality Management System Staff (QMSS), Regional Quality System Manager, Medical Device Investigator, and Compliance Officer. As QMSS Director, Karen managed successful audits with international regulatory partners, led the development of the first QMSS outcomes based strategic plan, and successfully led a team to achieve ISO 17025 laboratory accreditation within 6 months. In other roles, Karen contributed to joint FDA/industry initiatives to advance the quality of medical devices and has conducted numerous FDA inspections of domestic and foreign medical device manufacturers. Karen is an ASQ Certified Biomedical Auditor (CBA) and Certified Manager of Quality/Organizational Excellence (CMQ/OE). Karen earned an MBA from Northwestern University’s Kellogg School of Management and holds a BS in Chemical Engineering, also from Northwestern.  

Post Dinner Synopsis:

Topic: Developing Talent – Developing Quality Competencies of First and Early Career Individuals.

 Speaker – Daryl Bechdolt

Daryl Bechdolt will provide an overview of Schneider Electric’s Continuous Improvement Development program branded “El CID”. The targeted three-year program offers early career and college graduates a chance to develop quality and continuous improvement competencies and learn from experienced continuous improvement belts. Daryl will review the structured process which provides the participants a roadmap and toolkit to advance their careers while adding value to Schneider Electric.

 

Save the Date for ASQ Section 1304 St. Louis Conference

November 3, 2016

ASQ St. Louis Section 1304 Conference
November 3,  2016

Kick off World Quality Month by participating in our one-day Conference
Quality – Today to Tomorrow

Hosted at:
Millennium Student Center
University of Missouri – St. Louis
1 University Blvd.
St. Louis Missouri, MO 63121

Questions:  conference@asqstl.org or Mark Lynch 636.541.3196
Futher information:  www.asqstl.org

 

RAPS Chicago Chapter: The Shifting Risk Landscape for BioPharma and What’s Next for Pricing and Patient Access

 

 

The RAPS Chicago Chapter invites you to kick off the spring by joining us for a double header. We’ll be conducting two programs on 5 and 6 April, and are offering a discounted registration if you attend both.
Early Preparation is Key to Successful FDA Panel Reviews
5 April 2016
5:30-8:30 pm
AbbVie
Abbott Park, IL
  • Understand the process leading up to an Advisory Committee or Device Panel meeting, for both the Sponsor and FDA
  • Understand all the essential steps necessary to be successful at an FDA Advisory Committee meeting
  • Identify key project activities that can be strengthened by incorporation of panel considerations
  • Staff a team of internal personnel and external advisors to properly prepare for an FDA Advisory Committee meeting
  • Strategize opportunities for improving the chances of success

Speaker:
Susan Resnick, PhD, executive consultant, 3D Communications

Register Today
The Shifting Risk Landscape for BioPharma and What’s Next for Pricing and Patient Access
6 April 2016
5:30-8:30 pm
AbbVie
Abbott Park, IL
  • Identify key issues affecting the market access landscape
  • Apply potential models for creating and communicating a product’s value
  • Integrate new ideas for communicating a product’s rationale for patients, providers and payers

Speaker:
Jane Horvath, MHSA, market access lead, 3D Communiations

Register Today
Register for both and save…
RAPS is offering a discounted registration fee when registering for both events. Contact RAPS customer service at +1 301 770 2920 ext. 200 to get the special rate.

Local Contact:
Carol Cooper, RAC, RAPS Chicago Chapter Co-Chair
Joe Orlowski, RAC, RAPS Chicago Chapter Co-Chair

RAPS Contact:
Wesley Carr, +1 301 770 2920

 

Announcing ASQ Human Development & Leadership Webinar

Quality Leadership… The Legacy of a Lifetime!
Each of us will leave a legacy…In our work and with our families. The only question is…will it be the one that we want? The new ISO 2001:2015 Standard addresses Quality Leadership both directly and indirectly. We will explore these changes and what they mean to us and how we can use these to improve our contributions to our profession and our organizations! This webinar will explore changes in Risk-Based Thinking, identify specific tools we can apply to comply with the new Standard, and ways we can address our much needed cultural changes as well as how we as Quality Professionals can influence our organizations way of doing business to not only comply with the new Standard, but to ensure we leave a legacy that’s both lasting and meaningful.
Date: Tuesday, April 5, 2016

Time: 6:00 pm – 7:30 pm CT

Topic: Leadership and quality

About our presenter:
JR McGee is a Certified Master Black Belt Sensei and designed and implemented the MBB program at Lockheed Martin and has trained more than 30,000 Green Belts, 10,000 Black Belts, and certified 73 Master Black Belts. He has facilitated and coached more than 700 LSS projects. As Program Manager at “Top Gun” ranges world-wide, J.R. specialized in operations, training, and development of Fighter Pilots, Special Forces, Combat Field Engineering, and providing operational support to Intelligence and Counter-Terrorism operations around the world. He authors an Executive Coaching column for Quality Forum Magazine. He was awarded the ASQ Roger Berger Award for outstanding leadership support for Quality Knowledge and Operational Excellence to the Global Quality Community. He sits on the Board of Directors for the ASQ NextGen Program for Future Leadership Development for Quality Management. He holds a Degree in Electronic Technology from Troy State University (European Div); a Degree in Business Management from the University of Maryland; He completed the Strategic Studies Program at the Tepper Carnegie Mellon Business Institute; and the Strategic Leadership Program at the Goizueta Business School, Emory University. He is currently the CEO of XStream Leadership Group.

Sponsor Confidential: Influencing Effective Sponsor Behavior

ASQ Minnesota Section

shares an open invitation to a complimentary webinar:

 

Date: Wednesday, March 9th 12 pm CST

Location: One hour interactive webinar.

Overview:
This session will help you to influence and engage Sponsors differently to increase the likelihood they demonstrate the behaviors required for project success.

What you will receive:
* Learn the three criteria that will assure you have the right project sponsor and the six key responsibilities of every sponsor.

* Discover the most common types of sponsorship problems.

* Use an FMEA-type assessment tool to diagnose and decode your sponsor’s behavior patterns, determine common and unique causes of those behaviors, then determine appropriate influence tactics.

* Explore four common causes for sponsor underperformance, including recommended tactics and ‘quotables’ you can use immediately.

Register Now ButtonDelivered By:
Our conference leader is Kimberlee Williams (former Head of Global Change Execution at Merck & Company and Lean Sigma Black Belt). Now President at Center for Strategy Realization, Kimberlee works with professionals in top companies around the world on developing their change leadership capabilities. She provides capability building workshops, certification, advisory services, assessments, and methodology integration. Kimberlee will be sharing methods, stories, and experiences gained from her work on initiatives values at more than $4BB to help you build your Professional Net Worth and become even more effective in influencing the leader behaviors needed to fully realize the business benefits of your projects!

– See more at: http://mnasq.org/spotlight/sponsor-confidential/#sthash.4CmGNKQE.dpuf

Career Opportunity at Ameda

Ameda, Inc.

485 E Half Day Rd., Suite 320

Buffalo Grove, IL 60089

 

Job Title:  Regulatory Affairs Specialist

 

Location – Buffalo Grove, IL

We are seeking an experienced regulatory affairs specialist to participate in and guide teams involved in the production, marketing, and distribution of Class I and II electromechanical devices and disposables to verify that all functions are operating according to regulations. The Regulatory Specialist must keep abreast of legislative developments in the countries or regions in which products are distributed, and advise and strategize with management, keeping them informed of the implications of regulatory developments and advising on methods to execute plans as needed.

Responsibilities include:

  • Monitor applicable regulatory requirements; assure compliance with internal procedures and external standards
  • Compile and maintain 510(k), Technical File and other regulatory files, in a format consistent with requirements. Complete memos to file assessing changes.
  • Develop regulatory project plans, and align with global, regional and local marketing strategies.
  • Prepare, review, and approve labelling and SOP’s
  • Complete product and facility registrations, license extensions and amendments, renewals according to agreed timeline, and ensure approvals in a timely manner for regions in which Ameda distributes.
  • Maintenance of regulatory databases
  • Provide front and back room assistance for audits.
  • Provide support for responding to audits.
  • Maintain Health Canada regulatory licenses.
  • Maintain Certificates of Conformance for the EU.
  • Providing regulatory advice and support for new product development.
  • Unique Device Identifier (UDI) implementation and maintenance

Experience

  • Min 5-8 years regulatory experience in medical device industry with products marketed in the US, EU, and Canada.
  • BS degree in a technical discipline.
  • Experience filing 510K and other submission packages.
  • Proficient in 21 CFR 820 and the Medical Device Directive, and Canadian Medical Device Regulations.
  • Working knowledge of FDA and international regulations.
  • Working knowledge of quality management systems.
  • Experience dealing with notified bodies.
  • Working knowledge of 13485 and CE mark requirements.
  • Working knowledge of MDR Reporting.
  • Experience conducting internal audits and writing audit respons

Essential Skills

  • Sound basis of Regulatory and scientific knowledge
  • Attention to detail and commitment to
  • Ability to manage complex projects and timelines in a matrix team environment
  • Written and verbal communication and presentation skills
  • Ability to independently identify compliance risks and escalate when necessary
  • Thorough knowledge of applicable procedures, specifications, regulations and standards.
  • Organized in self, work and environment
  • Able to work in a matrix and cross-cultural environment
  • PC skills including Word, Excel, and interest and ability to learn other programs as required

Competencies

  • Excellent interpersonal skills.
  • Proficient in technical writing and oral communication.
  • Experience researching regulatory requirements.
  • Ability to plan, execute, and complete projects in timeframes allotted.
  • Ability to work independently.

Required Behavioral Competencies

  • Quality Orientation – Accomplishes tasks by considering all areas involved, no matter how small; showing concern for all aspects of the job; accurately checks processes and tasks; is watchful over a period of time.
  • Builds Strategic Working Relationships – Develops and uses collaborative relationships to facilitate the accomplishment of work goals.
  • Facilitates Change – Encourages others to seek opportunities for different and innovative approaches to addressing problems and opportunities; facilitating the implementation and acceptance of change within the workplace.
  • Manages Work – Effectively manages one’s time and resources to ensure that work is completed efficiently.
  • Decision Making – Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions; use effective approaches for choosing a course of action or developing appropriate solutions; take action that is consistent with available facts, constraints, and probable consequences.
  • Initiates Action – Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
  • Contributes to Team Success – Actively participates as a member of a team to move the team toward the completion of goals.

 

Milwaukee Section: Quality and Leadership Training

 

Greetings from the ASQ Milwaukee Section

EIn the past many attendees have come from outside the Milwaukee section and we believe we are offering your members a service by providing high quality education at a very reasonable cost.

When:

Saturday Feb. 27 and March 5 2016, 8:30 to 4:30 each day.

Where:

MRA Building I94 and WI-164 Waukesha.

How Much:

$295 for one day, $450 for two days.

Course offerings have been finalized and are offered in 4 tracks; Data Tools, Improvement Tools, Lean Management, and Quality Systems. Please visit the Section Website www.asqmilwaukee.org for additional information and to register.

Panorama map of Milwaukee, with a view of the ...

Panorama map of Milwaukee, with a view of the City Hall tower, ca. 1898 (Photo credit: Wikipedia)

 

Job Posting: Supplier Quality Engineer for Kemper Valve & Fitting Corp.

Kemper Valve & Fittings Corp. has been manufacturing and selling high-quality pressure pipe unions and related oilfield fluid control products in the United States since 1965. The employees of Kemper Valve & Fittings share a common commitment to the quality of the products we’ve been making for over 40 years. To this day, despite our steady growth and the increasing depth of our catalog, Kemper products continue to be 100% manufactured, certified and serviced in the U.S.A.

What Makes this a Great Opportunity?

This is a ground floor opportunity for the Supplier Quality Engineer to develop processes and procedures of the quality department, and be instrumental in growing this key area.

Be a part of a privately owned company that cares about it’s employees-we also offer benefit package that is outstanding.

Summary:

Address and resolve quality related issues with suppliers. Issue Supplier Corrective actions and follow them to completion to insure that incoming product quality is continually improving. Understand supplier process. Communicate KVF requirements to suppliers and insure those requirements are met. Monitor supplier performance, as well as guide supplier corrective actions. Act as supplier quality representative in daily MRB meetings.

Requirements:

The ideal applicant will possess integrity, a strong work ethic and ability to relate well to people on many different levels. A self-motivated individual, able to multi-task under pressure in a fast paced environment, will find success at Kemper.

  • 5 years documented experience as a Supplier Quality Engineer
  • Strong background in metallurgy of low-Carbon, High-alloy steels
  • Bachelor’s degree in Engineering or Science
  • ASQ Certified Quality Auditor
  • Two years experience with Metal Processing (Forging, Casting, heat treating, machining
  • ISO-9001 audit experience-ASQ CQA a plus
  • Familiarity with API Q1 quality systems
  • Willingness and ability to travel 40% of the time or more (home most weekends)
  • Benefits:

Kemper Valve and Fittings offers a potential bonus, based on individual performance and company profitability. Benefits include: health and dental insurance, life insurance, generous 401(k) retirement plan, and profit sharing plan.