
Our Fortune 500 Medical Device client has an exciting opportunity for a Supplier Quality Assurance Engineer II.
Job Summary:
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.
Responsibilities:
Drives improvement and corrective actions in the quality of components sourced from outside suppliers.
Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Manufacturing/Test operations, Commercial Sourcing, Design Assurance, R&D
Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
Exercises authority and judgment within
generally defined
practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit
Plans and organizes non-routine tasks with approval. Initiates or
maintains
work schedule and priorities. Plans and organizes project assignments and
maintains
project schedules
Works under general direction
regarding
the direction and progress of projects and special assignments. Independently
determines
and develops approach to solutions. Interprets,
executes
and recommends modifications to company policies.
Assists
in
establishing
departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives
Establishes
and cultivates a wide range of business relationships to
facilitate
completion of assignments. Interacts with suppliers. Participates in
determining
goals and
objectives
for projects. May lead projects within the function or department and/or
represents
a specialized field in larger project teams. Influences middle management on business solutions
Contributes 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,
demonstrates
a primary commitment to patient safety and product quality by
maintaining
compliance to the Quality Policy and all other documented quality processes and procedures.
Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality Systems
Required Qualifications:
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
Preferred Qualifications:
Experience with or lead auditor certification to ISO13485, 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
Quality
Systems Duties and Responsibilities:
Build Quality
into
all aspects of their work by
maintaining
compliance
to
all quality requirements.
Other
Details
:
Schedule: 08:00:AM - 04:30:PM
Work Setup: Hybrid - 3 days onsite in Arden Hills, MN
Contract Length: 9 Months (10/27/2025 - 7/26/2026)

♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.
𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻:
We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡.
𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬:
☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success.
☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.
☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.
𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆
Over 20 Technical Transfers and 30 product launches.
11 FDA remediations. Warning Letters and or Consent Decrees.
Cost savings and increased efficiency of over 10MM for clients