Staff Specialist, CAPA
Company: Stryker Corporation
Location: Flower Mound
Posted on: June 12, 2021
Stryker is one of the world's leading medical technology
companies and, together with our customers, is driven to make
healthcare better. We offer innovative products and services in
Orthopaedics, Medical and Surgical, and Neurotechnology and Spine
that help improve patient and hospital outcomes. We are proud to be
named one of the World's Best Workplaces and a Best Workplace for
Diversity by Fortune Magazine. Learn more about our award-winning
organization by visiting stryker.com
Who we want
Analytical problem solvers. People who go beyond just fixing to
identify root causes, evaluate optimal solutions, and recommend
comprehensive upgrades to prevent future issues.
Dedicated achievers. Relentless about quality, people who thrive
in a fast-paced environment and will stop at nothing to ensure a
project is complete and meets regulations and expectations.
Collaborative partners. People who build and leverage
cross-functional relationships to bring together ideas,
information, use cases, and industry analyses to develop best
What you will do
The Staff Specialist, CAPA will be primarily responsible for the
oversight of the CAPA process and procedures, and ensure it is
compliant, effective and efficient in dealing with quality issues.
The Staff Specialist, CAPA will, through expertise in problem
solving methodology, facilitate proactive and effective resolution
Working within the QMS team, under minimal supervision, ensure
compliance to 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 extension requests.
- Liaise with relevant functional groups, facilitate and mentor
teams through all stages of the NC / CAPA process.
- Contribute in developing optimum future state of the NC / CAPA
process for business needs, aligned with Corporate
- Develop & deliver training and coaching for new CAPA users on
CAPA principles and on the system
- Coordinate between potential different organizations which have
- Ensuring users provide the necessary rigor to the eCAPA system
content including maintaining a live document with all relevant
evidence attached, in a timely manner.
- 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
- Subject Matter Expert on all related procedures, ensuring
compliance to the relevant Corporate procedures. Super user of
- Lead & execute the NC/CAPA Review board forums. Chair and lead
Global/ multi-site forums.
- Manage & monitor site NC/CAPA KPIs including reporting
requirements, provide detailed updates and information in support
of quality & business review forums, also liaising with other GQO
sites to ensure compliance to global requirements & metrics are
- Ensure adequate training is developed, maintained and provided
to all users of CAPA process & systems.
- Identify and lead continuous improvement and collaboration
opportunities, promoting development and implementation of quality
data and reports for improvement and optimization of business
processes / results.
- Provides review and input into global procedures.
- Identify opportunity for improvement, lead &/or participate
in cross-plant and corporate project teams in areas of CAPA and
quality systems improvement.
- Lead/coordinate preparation, participate and follow up to
Stryker Internal, Corporate and third party compliance audits.
What you need
- Bachelor degree in a Science, Engineering or related
- Masters of Science, Engineering preferred
- Minimum of 4 years' experience in area of quality systems or
engineering or equivalent experience, with minimum of 2 years'
experience in area of CAPA.
- Minimum of 6 years in Quality/Regulatory Affairs environment
- Experience in interacting with regulatory agencies (FDA, MoH,
TUV, etc.) required.
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying
for this position. Learn more about our employee referral
Keywords: Stryker Corporation, Flower Mound , Staff Specialist, CAPA, Other , Flower Mound, Texas
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