Quality Assurance Specialist
4 weeks ago
A leading medical device manufacturer in the Western Suburbs of Chicago is seeking a Quality Assurance Engineer to enhance their expanding Quality team.
Job DescriptionKey Responsibilities:
- 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.
- Reviews 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.
- 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 tools and 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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