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Staff Advanced Quality Engineer

2 months ago

Shirley, United States Stryker Full time

Work Flexibility: Hybrid or Onsite

Stryker is hiring a StaffAdvanced Quality Engineer (Hybrid) to support the Stryker Spine division in Shirley, Massachusetts to work as development partner with the product design & development teams and evaluate new products & existing product modifications to the applicable requirements of Design and Change controls. This Engineer will lead and own risk management activities to ensure the highest level of product and process quality.

Workplace Flexibility (Hybrid): Candidate must reside within a commutable

distance to Shirley, Massachusetts as you will be expected to be onsite at the facility multiple times/week.

Who we want-

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
  • Self-directed initiators People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • User-focused creators. People who imagine with the user in mind, developing technology that helps change patients' lives.
What you will do:
  • Perform risk analysis and develop mitigation strategies, ensuring alignment with ISO 14971.
  • Collaborate with R&D, AQEs, and SQEs on risk management activities, including the Software Design Life Cycle (IEC 62304).
  • Guide Product Engineering through internal quality systems to ensure compliance with FDA, ISO, and other regulatory bodies.
  • Develop, modify, and execute regulatory-related company guidelines and procedures.
  • Review and evaluate project documentation for regulatory compliance and technical soundness.
  • Author technical assessments and participate in Health Hazard Evaluations, including discussions with medical professionals and regulatory agencies.
  • Support process validation programs for new and existing product development.
  • Develop and update procedures for incoming, in-process, and final inspections.
  • Provide quality perspective input throughout the design change process.
  • Collaborate with Design Engineers to develop robust verification test strategies.
  • Analyze failures using root cause analysis techniques.
  • Perform supplier development activities, including PPAP.
  • Conduct internal quality system audits and manage CAPA projects.
  • Educate Product Engineering on risk management tools, statistical methods, design and process control activities, and verification and validation test planning.
  • Train others on QA topics.
  • Coordinate and present Health Hazard Evaluations to the Risk Management Board and Corporate.
  • Participate in discussions with regulatory agencies regarding potential Product Field Actions.
What you will need

Required:
  • Bachelor's degree in science or an Engineering discipline required.
  • Over 5 years of engineering experience in the medical device industry, with foundational knowledge of FDA regulations, ISO 14971, and other relevant standards. Possesses strong expertise in quality concepts, including CAPA, audits, and statistics.
Preferred:
  • MS, CQE, or CRE preferred. Six Sigma Green or Black belt preferred
  • Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
  • Demonstrated ability to read and interpret CAD drawings.
  • Experience with software development life cycle (SDLC), preferably compliant with IEC 62304, IEC is a plus.
  • Working knowledge of effective implementation of all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process


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.

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