Zimmer Biomet · 22 hours ago
Sr. Supplier Quality Engineer
Zimmer Biomet is a global medical technology leader committed to enhancing patient mobility. The Sr. Supplier Quality Engineer will develop and maintain the supplier quality system while ensuring compliance and supporting product development and manufacturing processes for orthopedic products.
Health CareManufacturingMedical DeviceProduct Design
Responsibilities
Process Owner for Key Quality Processes: Supplier Management
Lead supplier qualification process. Interface with suppliers to ensure product compliance to specification and perform supplier audits as needed
Develop measurement techniques for product release at suppliers
Participating on project teams as a contributing member by providing supplier quality engineering support in the development of new suppliers and processes, and continuously improving company’s products and suppliers
Provide support for the manufacturing areas (external). Work with production personnel and supervision to determine and monitor quality metrics, samples plans and address non-conforming product issues. Lead corrective and preventive action investigations to resolve the root cause of problems
Auditing suppliers on time and per schedule
Writing audit plans and audit reports for suppliers to all applicable standards and regulations
Writing and reviewing of procedures, plans, protocols and reports to ensure regulatory compliance
Perform Mechanical Inspections and use typical equipment used in inspection
Assist with Design Transfer for release of new product development projects
Author and/or assist in the development and execution of process validations at suppliers
Perform statistical analysis for testing requirements and develop MSAs, TMQs, and inspection correlations
Assist suppliers in completion of Supplier Corrective Actions per appropriate timelines
Assisting project teams on compliance with purchasing requirements per FDA QSR, European MDD/MDR, ISO 13485 and other applicable ISO/EN standards
Capture and calculate supplier metrics on a regular basis
Develop relationships with employees and suppliers to ensure team-oriented operation
Accurately represents quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.)
Other duties as assigned
Qualification
Required
Bachelor's degree in Engineering or technical discipline
4+ years in related field, preferably medical device or manufacturing
Auditing experience, ISO 13485 preferred
Proficient in Machining methodologies (Titanium and Stainless-Steel experience best), 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) preferable
Process Validation experience
Basic Computer Skills (MS Office)
Benefits
Development opportunities
Robust employee resource groups (ERGs)
A flexible working environment
Location specific competitive total rewards
Wellness incentives
A culture of recognition and performance awards
Company
Zimmer Biomet
Zimmer Biomet is a medical device manufacturing company that offers orthopedic reconstructive, spinal, and trauma devices.
H1B Sponsorship
Zimmer Biomet has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-02-20Post Ipo Debt· $1.75B
2016-12-14Post Ipo Debt· $1B
2001-08-03IPO
Leadership Team
Recent News
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2025-12-19
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