Senior Quality Engineer
About The Position
My client, a global manufacturer of plastics tooling and molding solutions for the medical device industry, is hiring a Senior Quality Engineer for its Wisconsin facility. You will lead new product quality efforts and serve as the direct link between the customer and the shop floor. This is a first shift, Monday through Friday role with a salary range of $90,000 to $110,000. The company is a global manufacturer serving medical device customers worldwide. This role offers a direct, customer-facing position shaping the quality system and provides a growth path to mentor quality engineers and back up the quality manager.
Requirements
- Background in medical device manufacturing, including FDA, ISO 13485, and ISO Class 8 cleanroom experience.
- Auditing experience.
- Comfortable driving process and cultural change as a quality subject matter expert.
Nice To Haves
- MedAccred exposure is a plus.
Responsibilities
- Lead quality planning for new products, including control plans, PFMEA, and inspection plans.
- Review and release batch records; approve engineering change packages.
- Develop and approve validation protocols, leading deviation and corrective action resolution.
- Facilitate complaint investigations and audits; liaise directly with the customer.
- Disposition nonconforming product, mentor quality engineers, and drive continuous improvement.
Benefits
- Growth path: mentor quality engineers and back up the quality manager.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
