Quality Engineer (Cleanroom) - Medical Device Manufacturing
Michael Page Saint Charles
About Our Client
Our client, a medical device manufacturer situated in the Saint Charles area, is seeking a Quality Assurance Engineer to join their growing Quality team. Their clients include prominent OEMs like Stryker and Medtronic. In this role, you will be responsible for customer communication, root cause analysis, corrective actions, and leading initiatives on the production floor to enhance efficiency.This organization is rapidly expanding and features an innovative product line that is making a significant impact in the medical device industry
Job Description
The Quality Assurance Engineer will be responsible for:
- Supports regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality control and assessment.
- Leads and implements various methodologies for product and process improvement.
- Reviews the adequacy and accuracy of changes to Bill of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, Control Plans, and more.
- Oversees the completion and maintenance of risk analyses.
- Manages the generation and completion of protocols and reports for test method validations.
- Collaborates with Manufacturing Engineers to review processes for new and existing products, coordinating process validations and capability studies, and recommending monitoring devices when appropriate.
- Develops inspection techniques and procedures to ensure product integrity in line with design specifications, responsible for writing, approving, and implementing Incoming, In-Process, and Final Inspection procedures.
- Ensures that the disposition of non-conforming materials meets all regulatory requirements and that corrective actions are adequate to prevent recurrence.
MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant- Relevant experience in Quality Assurance Engineering
- Bachelor's Degree in a Science-related field
- Over 3 years of experience in a cleanroom environment
- Strong background in medical device manufacturing
- Solid understanding of statistical tools and the effective use of Design of Experiments (DOE) for recommendations
- Excellent communication and interpersonal skills
- Familiarity with FDA regulations, EU MDR, ISO 13485:2015, 21 CFR, and cGMPs
- Competitive base salary ranging from $80,000 to $95,000, based on experience and skills
- Bonus potential of up to 5%
- Comprehensive benefits package that includes medical, dental, and vision coverage
- Life and Accidental Death & Dismemberment (AD&D) insurance
- Short-term disability coverage
- 15 days of paid time off (PTO) plus 10 holidays
- 401(k) plan with a 6% company match
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About Our Client
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About Our Client
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