Senior Quality Engineer

Job Description

Job Description

Senior Quality Engineer / Sr. QA Engineer

Menomonee Falls, WI area · Full-time · First shift, Monday-Friday

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.

Why you should apply

• Work for a global manufacturer serving medical device customers worldwide.
• Direct, customer-facing role shaping the quality system.
• Growth path: mentor quality engineers and back up the quality manager.
• First shift, Monday through Friday.
• $90,000 to $110,000

What you'll be doing

• 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.

About you

• Preferred Background in medical device manufacturing, including FDA, ISO 13485, and ISO Class 8 cleanroom experience.
• Auditing experience; MedAccred exposure is a plus.
• Comfortable driving process and cultural change as a quality subject matter expert.

How to apply

We'd love to see your resume, but we don't need it to have a conversation. Email Russ at View email address on us.fitly.work and tell me why you're interested. Or, if you do have a resume ready, apply here.