Pharmavise Corporation

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

Pharmavise Corporation  •  Saint Paul, MN (Hybrid)  •  2 months ago
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Job Description


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)

Pharmavise Corporation

About Pharmavise Corporation

♦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

Industry
Consulting & Advisory
Company Size
11-50 employees
Headquarters
Fort Lauderdale, Florida
Year Founded
2013
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