Job Information
Stryker Senior Staff Quality Engineer - NC/CAPA in Weston, Florida
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)
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.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.