Medical Devices Quality Assurance Specialist

2 days ago


Milwaukee, Wisconsin, United States Michael Page Full time
About Our Company

Our client is a leading medical device manufacturer in the Milwaukee area, with multiple locations across the US and over 5,000 employees.

Their clients include renowned OEMs like Stryker and Medtronic. This role will be responsible for all customer communication, root cause/corrective actions, and leading floor initiatives to increase efficiency.

Job Description

The Quality Engineer will be responsible for:

  • Supporting regulatory and agency inspections, audits, investigations, and inquiries regarding product design and manufacturing quality.
  • Leading and implementing various product and process improvement methodologies.
  • Reviewing the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
  • Leading the completion and maintenance of risk analysis.
  • Generating and completing protocols and reports for test method validations.
  • Interfacing with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommending process monitoring devices where applicable.
  • Developing various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval, and implementation of Incoming, In-Process, and Final Inspection procedures.
  • Ensuring that the disposition of non-conforming materials meet all necessary regulatory requirements and assure the adequacy of corrective actions to prevent re-occurrence.
Additional Responsibilities

The Quality Engineer will also:

  • Act as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
  • Work with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems. Also, lead each of these groups with capability studies and the application of statistical quality control which includes Cpk, DOE, Hypotheses Testing, etc.
  • Coordinate and lead the preparation of Quality Plans, including inspection, test, and gauge requirements for new product introductions.
  • Provide support to other quality engineers.
  • Perform other functions as required.


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