Senior Quality Engineer l Medical Device Manufacturer

About Our Client

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 Senior 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.

Job Description

The Senior 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 BOMs, 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.

Additional Responsibilities

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

What\'s on Offer

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