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 TrackWiseSix Sigma Green or Black belt certification.Master’s degree.Certified Quality Engineer (CQE) certification.Travel Percentage: 10%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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.