Zimmer Biomet is a world leader in musculoskeletal health solutions. 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.
The Quality Sr Engineer I is responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer Biomet Quality goals.
Principal Duties and Responsibilities
Provides guidance and approve supplier production processes during new product introduction (NPI) or continued purchasing activities in order to establish robust manufacturing processes to provide highest quality product.
Solve quality or production issues in a systematic problem-solving manner.
Resolves technical issues with suppliers on daily basis to maintain high product quality and on-time delivery.
Evaluate supplier change notification and coordinate with internal team and supplier to implement the changes.
Perform supplier qualification and audits according to company and industrial standards and procedures.
Audits suppliers per established schedule.
Establish and negotiate quality agreements.
Monitors and evaluates supplier performance.
Provides feedback to suppliers and collaborates with suppliers on improvement activities.
Identify and conduct continuous improvement activities including issue evaluation, CAPA and/or supplier CAPA’s.
Formulates procedures, specifications, and standards for Zimmer products and processes.
Drive compliance and quality goals with suppliers and internal team.
Expected Areas of Competence
Experience in production process approval, design control, process validation, GR&R, risk analysis, FMEA, control plan, FAI.
Good knowledge of blueprint reading and geometric dimensioning and tolerancing (GD&T)
Understand statistical tools to control manufacturing processes.
Good understanding of FDA 21 CFR 820, ISO 13485, EU MDR and other international and regional regulation and standards.
Ability to multi-tasking and balance priorities to meet dynamic business goals.
Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
Ability to deliver, meet deadlines and have results orientation.
Able to communicate both orally and in written form to multiple levels of the company.
Demonstrates characteristics of high potential for future development opportunities.
Microsoft Office Suite
Perform other duties as assigned.
Education/Experience Requirements
A minimum of a Bachelor's Degree or equivalent in Engineering is required, or an alternative Bachelor’s degree program along with certification as a Quality Engineer (e.g. CQE) is required.
A minimum of 3 years of industry experience in a Quality Engineering role is required, or an equivalent combination of education and experience.
Certification as a Quality Engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) is preferred
Combination of education and experience may be considered (in evaluating experience relative to requirements)
Travel Requirements
Up to 20%
Additional Information
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.
