Quality Engineer – ISO13485

Leverage your quality leadership and ISO13485 experience for an industry-leading company in the Twin Cities Metro!

• A leader in their industry with 50 years in business
• ISO 13485 certified
• FDA and ITAR registered
• 100+ employees
• Privately held
• A place for people who care about their work and co-workers and know how to have FUN!

• Merit-based compensation, Recognition gifts, and Performance awards
• Medical, Dental, and Vision insurance
• 401k with company match
• Paid time off and holidays
• Company-sponsored events and more!

As a Quality Engineer, you will play a key role in leading development activities, including supporting part validation, qualification, and sustaining programs.

• You will act as the primary contact for customer quality concerns and directly support the production and engineering departments in resolving these concerns.
• Participate in the overall Stage-Gate approach to product realization, managing APQP and PPAP activities for new and modified programs.
• Conduct Quality Planning: create Process Flow Diagrams, Process FMEA, and Process Control Plans. Prepare work instructions and inspection instructions.
• Oversee PPAP/validation for purchased materials and components, ensuring compliance and quality.
• Implement pre-launch and early containment activities while preparing necessary reports.
• Foster and enhance relationships with customers and suppliers through strong leadership and direct engagement.
• Make decisions on materials placed on hold within the company.
• Participate in creating and managing CAPAs, SCARs, RMA activities, and sustaining programs.
• Write and issue Quality Alerts as needed.
• Develop and perform validation protocols.
• Collaborate with customers and employees to provide consultation on quality issues and conduct training related to the Quality Management System.
• This position reports to the Quality Manager and will interact with many functions of the company so your success will be recognized!

• 4+ years of experience in quality engineering, specifically within an ISO 13485-certified or highly regulated manufacturing environment.
• Experience with APQP, PPAP, IQ, OQ, PQ, and SPC.
• Knowledge of ISO 9001, ISO 13485, or FDA regulations.
• Strong capabilities in print reading, cGMP/GDP, GD&T, and cosmetic specifications are advantageous.
• Proven ability to manage multiple projects.
• Ability to manage time while juggling multiple responsibilities.
• Understanding of injection molding processes preferred.
• Excellent communication and interpersonal skills to build positive relationships with internal and external customers.
• A Bachelor’s degree in a relevant field is a plus.

Interested? Inquiries can be sent to