Quality Senior Engineer II (679720)
Zimmer Biomet

Jacksonville, Florida

Posted in IT
11 days ago

This job has expired.

Job Info

Job Summary

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.

Provide quality support for New Product Development Teams and Commercialization to ensure new/improved medical device products and processes are in compliance with applicable standards and regulations. Responsible for gathering relevant, factual information and data in order to solve quality related problems. Resolve issues by identifying and applying solutions from acquired technical experience and guided precedents. Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines. Work effectively/ productively with all departments by developing a team atmosphere. Interacts with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer Quality goals.

Principal Duties and Responsibilities
  • Lead and participate in risk management activities
  • Confer with vendors to qualify product and work with supplier quality to qualify vendors
  • Design and implement inspection methods, equipment, acceptance criteria and sampling plans
  • Initiate cost reductions of product inspections
  • Ensure effective design control and transfer to production
  • Provide validation, sampling, and statistical analysis support to other functions in the organization
  • Lead quality issue resolution by applying root cause methodologies
  • Perform First Article Inspections to ensure Manufacturing process capability
  • Evaluating process methods and equipment to meet performance and quality requirements
  • Establishing quality plans for equipment and processes for general and specific product performance needs
Expected Areas of Competence
  • Limit gauge design for dimensional verification
  • Problem solving using root cause methodologies (i.e. DMAIC, The Shainin System, Ishikawa)
  • Knowledge of statistics, process control, and process capability
  • Applying statistics and software in data analysis (example Minitab)
  • Application of Risk management ISO 14971 and failure modes and effects analysis (FMEA)
  • Working with suppliers to design inspection systems and resolve quality issues
  • Use of Computer Aided Drafting Software package (i.e. Solidedge and Solidworks)
  • Knowledge of design control requirements per ISO 13485 and 21 CFR part 820
  • Quality system regulations and requirements (i.e. 21 CFR part 820, ISO 13485, ISO 9001, ISO 14971)
  • Geometric Dimensioning and tolerancing (GD&T)
  • Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
  • Able to communicate both orally and in written form to multiple levels of the company.
Education/Experience Requirements
  • BS in engineering or an alternative Bachelor's degree program
  • Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.
  • 5+ years experience in a Quality Engineering role; Medical device strongly preferred, or an equivalent combination of education and experience.
  • Combination of education and experience may be considered (in evaluating experience relative to requirements)
Travel Requirements
  • Up to 20% for employees working with Suppliers
Additional Information

EOE M/W/Vet/Disability.

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.

This job has expired.

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