Quality Management Systems Sr Specialist
hace 1 día
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 talent 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. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.
What You Can Expect- How You'll Create Impact- Provides coaching for CAPA investigation from initiation through containment, root cause analysis, implementation, and verification of effectiveness.
- Provides facilitation and coaching on the problem solving process and challenges technical content.
- Interfaces with CAPA owners/teams to coach and facilitate progression through CAPA process.
- Assists with risk analysis of issue and ensures proper containment actions are applied.
- Verifies all procedural CAPA requirements are met.
- Assists to identify and escalate resource constraints/requirements, as applicable.
- Reviews CAPA files to ensure the files are audit ready, clearly tell the story, contain all required objective evidence, etc.
- Other quality tasks, as requested.
- What Makes You Stand Out- Ability to work within a team environment and build relationships outside of the department.
- Strong interpersonal and conflict resolution skills.
- Demonstrated CAPA experience.
- Detail oriented.
- Ability to deliver, meet deadlines and have results orientation.
- Able to communicate both orally and in written form to multiple levels of the company.
- English proficiency.
- Strong technical writing skills.
- Microsoft Office Suite, expert knowledge of root cause analysis, and understanding of QSR/ISO regulations.
- Knowledge of statistics, process control, and process capability a plus.
- Your Background- English proficiency required (C1)
- B.S. 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) a plus.
- Corporate CAPAS experience within the Medical Devices industry
- Minimum 3 years experience in a Quality Engineering role, or an equivalent combination of education and experience.
- Combination of education and experience may be considered (in evaluating experience relative to requirements).
- Travel ExpectationsLess than 20%
EOE/M/F/Vet/Disability
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