- Weston, FL, 33326, US
- United States of America-Michigan-Kalamazoo
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Job description
Senior Staff Quality Engineer - NC/CAPA
Stryker is hiring a Senior Staff Quality Engineer in Weston, FL or Kalamazoo, MI! In this role, you will provide quality engineering leadership and technical guidance in quality assurance and preventative activities, with a strong focus on continuous improvement of products and processes. You will advocate for and lead the execution of initiatives and projects aimed at enhancing quality performance within the business and for our customers. Additionally, you will mentor and provide technical direction across multiple areas of expertise, while ensuring compliance with regulations and standards.
Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility. You should be comfortable working onsite multiple days per week.
What you will do:
- Recognized process owner for NC/CAPA and/or other quality areas.
- Work closely with sales/marketing/field personnel, and cross-functional teams to assess quality performance and address top quality issues.
- Work closely with Digital, Robotics & Enabling Technologies (DRE) internal customers (Stryker Commercial Businesses) to assess DRE quality Performance.
- Mentors, executes, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
- Provides input into local, global, and corporate processes, represents function on review boards and teams.
- Review and approval of change management activities, challenges effectiveness and drives strong review.
- Consolidates and analyses Quality data, interpret KPI trends, drive continuous improvement process.
- Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
What are we looking for:
Required
- Bachelor’s degree in science, engineering, or a related discipline.
- 6+ years of experience in a regulated environment.
- Understanding of US and International Medical Device Regulations.
- Familiarity with ISO 13485, QSR, Good Documentation Practice, Good Manufacturing Practice.
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Post Market Surveillance, Statistics).
Preferred
- Previous industry experience.
- Experience interacting with regulatory agencies (e.g. FDA, MoH, TUV, etc.)
- Experience with TrackWise
- Six Sigma Green or Black belt certification.
- Master’s degree.
- Certified Quality Engineer (CQE) certification.