Supplier Quality Engineer

This range is provided by Bio Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

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The Quality Process Engineer is a senior contributor responsible for ensuring that supplier-provided materials and components consistently meet internal quality, reliability, and manufacturability requirements. This role provides technical leadership across supplier quality, internal process optimization, and continuous improvement initiatives throughout the supply chain. The Quality Process Engineer owns key quality systems and methodologies—including PPAP, PFMEA, Control Plans, and KPI management—and serves as a primary interface between suppliers and cross‑functional internal teams.

This position plays a critical role in driving corrective and preventive actions, ensuring regulatory and standards compliance, and supporting successful product realization from prototype through full‑scale production.

• Lead the development, optimization, and standardization of manufacturing and quality workflows to support efficient, scalable, and high‑quality production.
• Serve as the technical lead for root cause analysis, corrective and preventive actions (CAPA), material review board (MRB) activities, and supplier quality investigations.
• Own and maintain PFMEAs, Control Plans, and related quality documentation, ensuring alignment with engineering requirements and manufacturing processes.
• Establish, monitor, and analyze quality KPIs to identify trends, manage risk, and drive data‑driven continuous improvement initiatives.
• Support new product introductions, prototypes, pilot builds, and validation activities, ensuring quality readiness prior to production release.
• Ensure compliance with applicable quality systems, regulatory requirements, and industry standards, including ISO 9001, ISO 14001, ISO 13485, and ISO 45001.
• Act as a key liaison with suppliers, leading quality issue resolution, performance improvement initiatives, and ongoing supplier development efforts.
• Manage and facilitate supplier PPAP activities, including reviews, approvals, and ongoing compliance throughout the product lifecycle.
• Collaborate closely with Engineering, Manufacturing, Supply Chain, and Operations leadership to proactively mitigate risk and improve overall product quality and performance.

• Bachelor’s degree in Engineering or a related technical discipline.
• 5+ years of experience in a manufacturing quality, supplier quality, or process engineering role with increasing responsibility.
• Six Sigma Green Belt required;
  Black Belt strongly preferred.
• Demonstrated expertise in structured problem‑solving methodologies and continuous improvement tools.
• Strong organizational, communication, and stakeholder management skills, with the ability to influence cross‑functional teams and external partners.
• Proficiency with standard office and quality management software tools.
• Willingness to travel up to 20% as needed to support supplier and manufacturing operations.

• Mid‑Senior level

• Full‑time

• Quality Assurance
• Medical Equipment Manufacturing and Appliances, Electrical, and Electronics Manufacturing

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Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance