Supplier Quality Engineer

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.

Paragon 28, a Zimmer Biomet Company focused on orthopedics medical devices for the foot and ankle, is hiring a Staff Supplier Quality Engineer. The Staff Supplier Quality Engineer is responsible for developing, implementing, and sustaining Paragon 28’s supplier quality relationships and supplier quality system. This role provides strategic and technical leadership across supplier processes to ensure they are capable, compliant, and aligned with the expectations of Paragon 28.

• Process Owner for Supplier Management, including supplier qualification, performance monitoring, and ongoing compliance oversight.
• Lead supplier qualification and onboarding activities, including supplier assessments, audits, and verification of product conformance to specifications and regulatory requirements.
• Provide technical leadership in the development and approval of measurement and inspection methods for product release at suppliers.
• Serve as a core contributor on cross-functional project teams, providing supplier quality engineering support for new supplier introduction, new process development, and continuous improvement initiatives.
• Support external manufacturing operations, partnering with suppliers and internal stakeholders to define quality metrics, sampling plans, and controls, lead investigation and resolution of nonconforming product(s) through root cause analysis and SCAR.
• Plan, conduct, and document supplier audits in accordance with applicable standards and schedules; author audit plans, reports, and follow-up actions.
• Support compliance with global regulatory requirements, including, but not limited to, FDA QSR/QMSR, ISO 13485, EU MDR, and other applicable standards, across purchasing and supplier-related processes.
• Establish, track, and analyze supplier quality metrics, using data to drive performance improvement and risk reduction.
• Develop strong working relationships with suppliers and internal teams, enabling collaborative problem solving and continuous improvement.
• Represent supplier quality processes during internal and external audits, including FDA, ISO 13485, MDSAP, and third-party inspections.

• Bachelor’s degree in Engineering or technical discipline.
• 8+ years in highly related field, preferably medical device or manufacturing.
• Auditing experience (Auditor), ISO 13485 Lead Auditor Certification preferred.
• Proficient in Machining methodologies (Titanium and Stainless‑Steel experience highly preferred), knowledge of hardness, passivation, surface treatments, cleaning techniques etc. for communication with Suppliers and Engineers.
• Familiarity with 21 CFR 820 and ISO 13485 and other Government / ISO Standards.
• Technical writing skills that include Quality Management Systems (QMS) and procedures.
• Proficient in Geometric Dimensioning and Tolerancing (GD&T) preferred.
• Process Validation experience.
• Basic Computer Skills (MS Office).

Travel should not exceed 30% of total time. Supplier travel will be needed for on-site audits and/or troubleshooting.

Salary: $100,000 – $135,000 USD Annually

EOE