Stryker Corporation

Product Field Action (PFA) Lead, (Hybrid)

Stryker Corporation • $102K — $171K *
Redmond, WA 98052In-Person
Healthcare
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Science, Engineering, Quality, or a related technical discipline.
  • 4+ years of experience in a highly regulated quality, manufacturing, engineering, or medical device environment.
  • Experience leading complex investigations with methodologies like 8D and Fault Tree Analysis (FTA).
  • Proficient in statistical analysis and risk-based methodologies.
  • Strong communication, collaboration, and stakeholder management skills.

Responsibilities

  • Establish standardized processes for field action assessments and investigations.
  • Lead and direct Senior Quality Assurance Engineers in key quality activities.
  • Conduct Product Field Action monthly Board reviews and strategy development.
  • Monitor KPIs to enhance the field action process and implement necessary improvements.
  • Mentor teams on risk management, investigation rigor, and field action expectations.

Benefits

  • Hybrid work flexibility from Redmond, WA or Portage, MI.
  • Opportunity to influence organizational safety and product quality standards.
  • Engagement in continuous improvement initiatives to enhance operational efficiency.
Full Job Description
Work Flexibility: Hybrid

This senior-level quality and post-market leader serves as the Site PFA Lead for the Belfast site and is responsible for overseeing Product Field Action Assessments (PFAA), Nonconformance (NC), and Corrective and Preventive Action (CAPA) processes. Partners across Quality, Regulatory Affairs, Engineering, Manufacturing, and Operations to protect patient safety, maintain product quality, and drive compliant execution of field actions in accordance with FDA, ISO 13485, and ISO 14971 requirements. This position is Hybrid in Redmond, WA or Portage, MI.

What You Will Do
  • Establish and maintain standardized process and procedure for executing field action assessments and executions, including but not limited to investigations and identifying solutions.
  • Lead and provide strategic direction to Senior Quality Assurance Engineers responsible for Product Field Action Assessments (PFAA), Non-Conformance (NC), and CAPA activities.
  • Lead Product Field Action monthly Board review
  • Develop strategies and plans for field actions in alignment with organizational goals and objectives.
  • Ensure alignment with current regulatory standards, including 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and applicable global regulations.
  • Identify potential risks associated with field action decisions and implement measures to mitigate them effectively.
  • Serve as the escalation point for complex investigations, risk evaluations, and cross-functional decision-making.
  • Monitor key performance indicators (KPIs) to evaluate the effectiveness of the field action process and implement improvements as necessary.
  • Mentor and coach Senior QA Engineers and broader teams on risk management principles, investigation rigor, and PFA expectations.
  • Collaborate with internal stakeholders, such as PFA assessment and execution owners, engineers, and technicians, to ensure seamless coordination and communication regarding field action deliverables.
  • Maintain a customer-centric approach by ensuring that field actions are completed promptly and meet or exceed customer expectations.
  • Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and safety of field action decisions over time.
  • Support internal and external audit activities relating to the PFA process.
  • Serves as the voice for the site (Belfast) in divisional and global meetings in the process area.
  • Updates key stakeholders and leaders on divisional record deliverables and progress.


What You Need
  • Bachelor's Degree in Science, Engineering, Quality, or a related technical discipline.
  • 4+ years of experience in a highly regulated quality, manufacturing, engineering, or medical device environment.
  • Experience leading complex investigations and applying root cause analysis methodologies such as 8D and Fault Tree Analysis (FTA).
  • Experience utilizing statistical analysis and risk-based methodologies.
  • Strong communication, collaboration, and stakeholder management skills.
  • Ability to manage multiple priorities and influence cross-functional teams to achieve desired outcomes.


Preferred Qualifications
  • Demonstrated Product Field Action (PFA) experience.
  • Experience in Post-Market Quality and product field action processes.
  • Prior project management experience.
  • Knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, and ISO 14971 requirements.
  • Excellent interpersonal, collaborative teamwork, and negotiation skills.
  • Proven ability to build trusted relationships across all levels of an organization.
  • Strong ability to develop and communicate detailed assessments, execution plans, and potential challenges.
  • Experience utilizing quality and project management systems such as: TrackWise, Microsoft Office Suite, SharePoint, Visio


United States of America Pay Ranges:
  • US15: $102,700 - $171,100 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 20%

About Stryker Corporation

Stryker Networks is a premier Information Technology partner providing IT managed services and database application development.

Stryker Corporation Careers

Joining Stryker Corporation means becoming part of a global team recognized for its commitment to innovation, leadership, and enhancing patient outcomes. As a leading medical technology company, Stryker is the perfect place to build a career that truly makes a difference.

Work You’ll Do

At Stryker, every position contributes to our mission of making healthcare better. Here, you will use your skills to work on transformative projects that improve lives across the globe. You will be part of a culture that thrives on growth, innovation, and leadership, and you will work alongside some of the brightest minds in the industry.

Innovative Careers

Stryker offers a range of job opportunities, from internships that provide a stepping stone into high-impact roles to leadership positions that drive strategic direction. Our team members benefit from a work environment that supports professional growth and diversity training, ensuring everyone, regardless of background, can thrive.

Be Part of a Great Team

Our employees enjoy a collaborative atmosphere that fosters innovation and encourages professional development. With a commitment to leadership and diversity, Stryker ensures that all team members have the opportunity to grow and influence the company's future. Our global scale and dedication to impactful solutions make us leaders in medical technology.

Future-Proof Your Career

Stryker is dedicated to career development, offering extensive training, benefits, and resources to help you advance professionally. From networking opportunities to workshops on resume and interview skills, we support your journey every step of the way. Our career paths are as diverse as the innovative products we develop and the markets we serve.

Explore Job Opportunities

Whether you’re just starting out or looking to take your career to the next level, Stryker provides the tools and resources to achieve your goals. We are continuously hiring and looking for ambitious, curious, and driven individuals to join our team.

Stryker Corporation – A Leader in Medical Technology

Our commitment to improving healthcare through innovative products sets us apart in the medical technology field. The synergy of our team’s expertise and our leadership in technology solutions enables us to meet the needs of our customers effectively.

Stay Connected

Join Our Team Search open positions that match your skills and interest. We look for passionate, creative, and solution-driven team players. Explore the many benefits of employment at Stryker, a company that values innovation and leadership.

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Stryker Corporation – Where Talent Meets Opportunity

At Stryker, we believe in turning the challenges of today into the breakthroughs of tomorrow. Join us in our mission to improve healthcare around the world.
Learn more about Stryker Corporation
Size
46,000 employees
Market Cap
$91.9 billion
Industry
Healthcare
Net Income
$1.5 billion
Founded
2004
5 Year Trend
+8.6%
Revenue
$14.3 billion
NASDAQ
SYK
* Ladders Estimates

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