Quality Engineer

Job 2592 - Quality Engineer - Contract located near Minneapolis, Minnesota

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high‑end leaders, managers and consultants to skill‑set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

As a Senior Supplier Engineer, you will be the bridge between the Client's Cardiac Diagnostics CDx cutting‑edge design leading the integration of new and existing technologies into CDxs global supply chain.

Your work will directly impact the reliability scalability and speed at which life‑changing devices reach patients.

As the technical lead, you will work with R&D, Quality, Operations and Regulatory team members to integrate OEM and sub‑system supplier designs along with supplied components into CDxs products to ensure compliance, performance and safety requirements are met.

This role has a wide scope of responsibilities ranging from ensuring supplier design assurance, supplier product development integration assurance and third‑party manufacturing assurance.

You will apply strong engineering fundamentals to analyze supplied designs, assess supplier process capabilities and drive corrective and preventive actions that enhance quality, reliability and manufacturability.

At CDx, collaboration across disciplines is key to our success. This position follows a hybrid work model requiring on‑site presence with key partners at least three days per week to support design assurance supplier technical discussions and cross‑functional problem‑solving.

• Working with Medical Device OEM, sub‑system and component suppliers to identify supplier specifications. The end goal is to successfully integrate supplied designs and components into CDxs development and manufacturing processes.
• Partnering with R&D, Design Assurance, Manufacturing Engineering, Operations Quality and Project Management to execute supplier control deliverables according to program needs. These deliverables include purchased material qualifications, supplier‑driven change assessments, supplier design or capability improvement projects, and regulated compliance assessments.
• Generating and reviewing quality plans agreements product specifications component qualifications design verification/validations and process validations.
• Investigating complaints and managing supplier investigations for both design and manufacturing‑related issues.
• Participating in supplier audits to assess design and manufacturing compliance to regulatory standards and CDx agreed specification requirements. Audit activities include the evaluation of audit observations and findings reporting follow‑up and confirmation of follow‑up actions.
• Acting as a technical expert to ensure repeatable and reproducible quality/reliability during the life of the product.
• Investigating and evaluating suppliers of new and existing technologies for use in future products or to improve quality/reliability of current products.
• Participating in risk assessment of supplier capability, supplier designs and supplier supply processes to support planning and execution including service risk mitigation measures to ensure continuity of supply for CDx.
• Coordinating all phases of supplier engineering work including content for projects and communicating emerging issues and recovery plans with site leadership and stakeholders to gain resources and support. Demonstrating a primary commitment to patient safety and product…