Our client is looking for a Quality Assurance Engineer to join their expanding team. This organization is experiencing rapid growth and is known for its innovative product line that is making a significant impact in the medical device industry. Our client is in the medical device industry and they're looking for their next engineer to join the team to help make an impact in the medical device industry.
Client Details
A medical device manufacturer based in the Western Suburbs of Chicago is seeking a Quality Assurance Engineer to strengthen their growing Quality team. Collaborating with top OEMs, this position emphasizes customer engagement, conducting root cause analyses, implementing corrective actions, and spearheading efficiency initiatives on the production floor. Known for its innovative product offerings that are reshaping the medical device industry, this rapidly expanding organization presents an exciting opportunity for those looking to make a significant impact.
Description
- 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.
Profile
- 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
Job Offer
- Competitive base salary between $80,000-$950,000, 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
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.