Company name: Zimmer Biomet
Type of industry, product or service: Medical Devices
Job Title: Sr Quality Engineer SQE
Location: Broadview Heights, OH
Requirements and Qualifications:
Principal Duties and Responsibilities
- 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
- Monitoring performance of processes to a standards
- Applying ISO and QSR requirements to processes and procedures for Zimmer and outside suppliers
- Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled
- Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations
- Developing and maintaining department and project budgets
Expected Areas of Competence
- Ability to work within a team environment and build relationships outside of the department as well as outside the company (suppliers, regulatory agencies, etc.).
- Facilitates team efforts on quality engineering projects.
- Ability to deliver, meet deadlines and have results orientation.
- Able to communicate both orally and in written form to multiple levels of the company.
- Microsoft Office Suite, expert knowledge of blueprint reading and geometric dimensioning and tolerancing, understanding of QSR/ISO regulations, design assurance, FMEA, and product testing methods, and are able to use optical comparators and CMMs.
- Knowledge of statistics, process control, and process capability
- Full working knowledge of all supporting department needs and capabilities, including the ability to discern when inaccurate information is supplied and offer ideas for how to correct it.
- Thorough knowledge base of existing Zimmer products and a basic understanding of competitive products
- BS in engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).
- Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.
- Minimum of 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)
- Up to 20%
- Up to 50% for employees working with Suppliers