Stryker Corporation

Senior CAPA Specialist

Stryker Corporation • $87K — $145K *
Mahwah, NJ 07430In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor’s degree in science, engineering, or a relevant technical field.
  • Minimum 2 years of experience in a regulated medical device or pharmaceutical environment.
  • Skill in managing nonconformance and CAPA processes with a focus on continuous improvement.
  • Expertise in root cause analysis and implementing corrective actions effectively.
  • Familiarity with FDA and international regulatory standards is preferred.

Responsibilities

  • Facilitate and coach teams on problem-solving methodologies to enhance CAPA effectiveness.
  • Partner with cross-functional teams to drive timely investigations and resolutions for quality issues.
  • Apply CAPA methodologies to support effective corrective and preventive actions.
  • Maintain comprehensive CAPA documentation within electronic quality management systems.
  • Contribute to CAPA review meetings and quality discussions across various teams.
  • Monitor CAPA metrics, prepare reports, and support quality and business reviews.
  • Provide guidance to stakeholders in applying quality system requirements consistently.

Benefits

  • Opportunity to work with a global leader in the medical device industry.
  • Engagement in cross-functional collaboration and innovation drives quality improvement.
  • Potential for professional development through training and continuous improvement initiatives.
  • Exposure to compliance and regulatory environments, enhancing marketability in quality operations.
Full Job Description
Work Flexibility: Onsite

Stryker is hiring a Senior CAPA Specialist for the Global Quality Operations team supportingthe Joint Replacement product portfolio in Mahwah, NJ. Working within the QMS team to ensure compliance with CAPA processes and procedures and is responsible to but not limited to.  Have responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity and timeliness. Review & Approval of CAPA changes including execution requests.                                                                        

What you will do

  • As Problem Solving Methodology expert, facilitate and coach NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
  • Support Nonconformance (NC) and Corrective and Preventive Action (CAPA) activities by partnering with cross-functional teams to drive timely investigations and resolution of quality issues.
  • Apply CAPA, root cause analysis, and problem-solving methodologies to support effective corrective and preventive actions.
  • Maintain accurate and complete CAPA documentation within electronic quality management systems (e.g., TrackWise), ensuring required evidence and records are documented.
  • Assist in facilitating CAPA review meetings and contribute to site, cross-functional, and global quality discussions.
  • Monitor CAPA metrics and trends, prepare reports and provide data to support quality and business reviews.
  • Provide guidance and support to CAPA process stakeholders, promoting consistent application of quality system requirements and procedures.
  • Participate in training, process improvement, and continuous improvement initiatives to enhance CAPA effectiveness and compliance.
  • Support internal, corporate, and external audits and contribute to quality system improvement projects and corrective action follow-up activities.

 

What you need

Required Qualifications

  • Bachelor’s degree or higher in science, Engineering or applicable technical field.
  • Minimum 2+ years’ experience working in a medical device or pharmaceutical regulated environment.
  • Demonstrated experience managing Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes, including root cause investigations, implementation of corrective actions, effectiveness verification, and continuous quality improvement initiatives.

Preferred Qualifications:

  • Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
  • Knowledge of U.S. FDA and international medical device regulatory requirements and quality system standards.
  • Experience in supporting Quality Systems (e.g.  Audits, Management review, Quality Planning).

  

 

$87,000 - $145,100 USD Annual


  

 

Travel Percentage: Up to 25%

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

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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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