Sr. Supplier Quality Engineer

Overview

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.

Paragon 28, a Zimmer Biomet Company, is hiring a Sr Supplier Quality Engineer. The position focuses on developing and maintaining the supplier quality system and related quality activities for Paragon 28 orthopedic products for the Foot and Ankle. This is a hybrid position located in Englewood, Colorado.

• 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, sample 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

• 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)

Salary Range: $90,000 - $110,000 USD annually based on skills and experience

Travel should not exceed 50% of total time. Supplier travel will be needed for on-site audits and/or troubleshooting.

EOE