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.