Sr. Supplier Quality Engineer

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

What You Can Expect

Paragon 28, a Zimmer Biomet Company is hiring a Sr Supplier Quality Engineer. The Sr. Supplier Quality Engineer is a quality engineering position that has emphasis on developing and maintaining Paragon 28's supplier quality system and related quality activities specifically relating to product development, manufacturing, and supply chain of Paragon 28 orthopedic products for the Foot and Ankle. This is hybrid position located at our Englewood, Colorado location.

How You'll Create Impact

• 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

Your Background

Compensation Data

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

Travel Expectations

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

EOE