Senior CAPA Analyst in Flower Mound, TX at Stryker Corporation

Date Posted: 8/17/2019

Job Snapshot

Job Description

Who we want


Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities

What you will do

As a Senior CAPA Specialist, you will perform the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborate with clients to develop positive and proactive approaches to regulatory compliance. Ensures that privacy and security standards are met and adhered to. May coordinate activities and assist with interactions during regulatory agency inspections. May direct interaction with regulatory agencies on defined matters. Assists with the corrective action implementation.

Responsibilities:

  • Ensure compliance to CAPA processes and procedures
  • Develop/review metrics for adverse trending analysis of non-conformities.
  • Ensure users provide necessary rigor to the eCAPA system content including maintenance of a live record with all relevant evidence attached in a timely manner.
  • Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.
  • Facilitate and coach NC and CAPA teams in the application of problem-solving techniques and promote its uses and development (e.g. human error reduction, 4-D, etc.).
  • Lead local NC/CAPA review board forums, may participate in global forums
  • Customizes Queries from eCAPA system and analyzes data based on KPIs to organize work
  • Act as a subject matter expert for eCAPA and CAPA procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
  • Monitor and drive completion of records to ensure on-time execution
  • Identify and lead local continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for the improvement and optimization of business processes and results.
  • Coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third-party audit activities.  Participate in Front Room Audit Capacities
  • Update local/ suggest updates to Global Procedures
  • Deliver training and coaching for new CAPA users on principles and system requirements.
  • Delivers training and coaching for new CAPA team members on principles and system requirements.
  • Participate in cross-site and corporate project teams in areas of CAPA and quality system improvement, may act as DPO
  • Utilize basic project management techniques

What you will need:

Basic Qualifications:

  • Bachelor’s Degree
  • Minimum 3 years’ working experience within Stryker, quality, engineering, manufacturing, regulatory or related role.  

Preferred Qualifications:

  • Bachelor’s Degree in science, engineering or related discipline
  • Experience working in CAPA, quality or regulatory

Work From Home: No

Travel Percentage: Up to 25%

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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