Quality Engineer - Global Medical Device Manufacturer
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Our client is a medical device manufacturer located in the Northern Suburbs of Chicago. With over 15 locations throughout the US and 5000 employees, they have continued to grow out new product lines. They seek a Quality Engineer to join their Quality team and oversee 3 production lines.
Our client is a medical device manufacturer located in the Wheeling area. With over 15 locations throughout the US and 5000 employees, they have continued to grow out new product lines. They seek a Quality Engineer to join their Quality team. Their clients include well known OEMs, such as Stryker and Medtronic. This role will be responsible for all customer communication, root cause/corrective actions and leading floor initiatives to increase efficiency.
The Quality 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.
- Acts 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.
- Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
- Coordinates and leads the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions
- Provides support to other quality engineers.
- Performs other functions as required.
- Bachelor's Degree (Engineering related), Master's Degree preferred
- 4+ years of experience in a manufacturing environment, specifically in metal working or medical device manufacturing preferred
- Project Management and Lean 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 ISO 9001:2015, ISO 13485:2015, 21 CFR and cGMPs
- Competitive base salary between $85,000-$100,000, depending on experience and skills
- Bonus opportunity up to 5%
- Comprehensive benefits package including Medical, Dental and Vision
- Medical/Prescription Drug Coverage - 3 Blue Cross Option (2 PPOs, 1 HDHP)
- Health Savings Account and Flexible Spending Accounts
- Dental Coverage - 2 Met Life Options
- Life and AD&D Coverage
- Short-term disability coverage
- 15 PTO Days + 10 holidays
- 401(k) with 3% company match
- Pet Insurance
- Tuition Reimbursement