Supplier Quality Assurance Engineer II — Medical Device; Hybrid — Arden Hills, MN

Supplier Quality Assurance Engineer II — Medical Device (Hybrid — Arden Hills, MN) Contract

Saint Paul, United States | Posted on 09/26/2025

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at  and follow us on Linked In:

Our Fortune 500 Medical Device client has an exciting opportunity for a Supplier Quality Assurance Engineer II.

The Arden Hills Supplier Quality Engineering team is looking for high-energy, driven, passionate people! The Supplier QA Engineer II will play a key part in leading performance improvement of suppliers and increasing the suppliers’ capabilities to consistently meet internal requirements. This role collaborates with cross-functional teams to address and resolve all component-related challenges throughout the supply chain. Additionally, the Supplier QA Engineer will support Global Sourcing, supplier manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects.

• Drive improvement and corrective actions in the quality of components sourced from outside suppliers.
• Assess and drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Manufacturing/Test operations, Commercial Sourcing, Design Assurance, R&D.
• Develop solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Have a broad knowledge of a variety of alternatives and their impact on the business unit.
• Plan and organize non-routine tasks with approval. Initiate or maintain work schedule and priorities. Plan and organize project assignments and maintain project schedules.
• Work under general direction regarding the direction and progress of projects and special assignments. Independently determine and develop approach to solutions. Interpret, execute and recommend modifications to company policies. Assist in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
• Establish and cultivate a wide range of business relationships to facilitate completion of assignments. Interact with suppliers. Participate in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influence middle management on business solutions.
• Contribute to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
• In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Assure that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy. Establish and promote a work environment that supports the Quality Policy and Quality Systems.

• BS degree in an Engineering related field, such as Mechanical Engineering, Materials Engineering, Chemical Engineering, Electrical Engineering, or similar technical degree with 2-3 years related experience.
• Experience in Quality Management Systems, regulatory compliance, and risk management.
• Experience with problem solving quality tools, Corrective/Preventive Actions (CAPA), Technical Documentation.

• Experience with or lead auditor certification to ISO
  13485, 9001, TS16949 standards.
• Ability to communicate cross functionally with suppliers, team members and leadership.
• Highly organized and detail-oriented with ability to manage multiple projects and prioritize effectively.

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Schedule:

08:00 AM - 04:30 PM

Work Setup:
Hybrid - 3 days onsite in Arden Hills, MN

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.