Quality Engineer (Cleanroom) - Medical Device
Michael Page Saint Charles
About Our Client
A medical device manufacturer in the Saint Charles area is seeking a Quality Assurance Engineer to join their expanding Quality team. Their clients include prominent OEMs such as Stryker and Medtronic. This role involves managing customer communications, leading root cause analysis and corrective actions, and driving initiatives to improve floor efficiency.The company is rapidly growing, with a cutting-edge product line that's 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 regarding the control and assessment of product design and manufacturing quality.
- Leads and implements various product and process improvement methodologies.
- Review the adequacy and correctness of changes to Bill of Materials (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
- Leads in the completion and maintenance of risk analysis.
- Leads generation and completion of protocols and reports for test method validations.
- Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
- Develops 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.
- Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
Please apply below, if you're resume looks to fit in with the job criteria. From there, Ben Aldrich from Michael Page will reach out in the next 48 hours if deemed a fit!
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law.MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant- Relevant Quality Assurance Engineering Experience
- Bachelor's Degree (Science Related)
- 3+ years of experience in a Cleanroom environment
- Strong Medical Device Manufacturing Experience
- Good knowledge of statistical tool sand appropriate use of Design of Experiments (DOE) when developing recommendations
- Excellent communication and interpersonal skills
- Working knowledge of FDA, EU MDR, ISO 13485:2015, 21 CFR and cGMPs
- Competitive base salary between $80,000 - $95,000, depending on experience and skills
- Bonus opportunity up to 5%
- Comprehensive benefits package including Medical, Dental and Vision
- Life and AD&D Coverage
- Short-term disability coverage
- 15 PTO Days + 10 holidays
- 401(k) with 6% company match
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About Our Client
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About Our Client
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