Stryker · 2 weeks ago
Staff Quality Engineer
Arlington, Tennessee
Full-time
Onsite
Senior Level, Lead/Staff
4+ years expStryker is a leading company in the medical device industry, and they are seeking a Staff Quality Engineer to ensure their products meet high standards of safety and performance. The role involves leading quality initiatives, managing compliance, and driving continuous improvement to positively impact patient outcomes.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Provide oversight and direction on product and process quality performance across operations and business functions
Lead and execute quality initiatives and projects at local and global levels to improve compliance and efficiency
Manage internal and supplier-driven non-conformances (NCs), ensuring timely investigation and closure
Own and coach others through Corrective and Preventive Actions (CAPAs), driving root cause analysis to completion
Interpret and act on KPI trends to implement continuous improvement strategies
Serve as a recognized process owner in areas such as risk management, validation, inspection processes, and statistical sampling
Participate in and lead internal and external audits, representing quality expertise and ensuring regulatory compliance
Support manufacturing transfers and manage product holds or potential product escapes to maintain quality standards
Qualification
Required
Bachelor's Degree in Engineering, Science, or a related field
4+ years of experience in a Quality or Regulatory Affairs role within a regulated industry
Preferred
Proficiency in medical device manufacturing processes and standards (ISO 13485, GMP)
Lean Six Sigma certification or training
Experience interacting with regulatory agencies (e.g., FDA, MoH, TUV)
Advanced knowledge of risk management practices, CAPA, audits, and statistical techniques
Familiarity with validation strategies and inspection optimization
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chair & CEO
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase