Staff Specialist NC CAPA

The Staff Specialist, NC/CAPA will be primarily responsible for the oversight of the NC/CAPA process and procedures, and ensure they are 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 of issues.

Furthermore the Staff Specialist CAPA is responsible for identifying and implementing significant systemic improvements, provide oversight to NC/CAPA owners to ensure accountability and monitor processes for efficiency, effectiveness, and compliance related to global Stryker NC and CAPA processes.

Key Areas of Responsibility

Will work within the site’s QMS structure, with responsibility to ensure an effective and efficient QMS is built and maintained, which includes, but not limited to:

• Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.
• Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process.
• Contribute in development of optimum future state of the NC/CAPA process for business needs in alignment with Corporate direction.
• 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.  
• Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
• Furthermore being the NC/CAPA Process Owner ensuring compliance to  the relevant Corporate and local procedures.
• Ensure adequate training is developed, maintained and provided according to local needs to all users of CAPA process & systems.
• Deliver and coach new eCAPA users and CAPA specialists on NC/CAPA principles and on the system.
• Manage and monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality and business review forums, liaise with other sites to ensure compliance to global requirements and metrics are achieved.
• Prepare, execute and lead the NC/CAPA Review board forums. 
• Lead and/or participate in multi-site and global forums.
• Identify and lead continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for the improvement and optimization of business processes and results.
• Lead and/or participate in cross-plant and corporate project teams in areas of NC & CAPA and Quality System improvement.
• Provides review and input into global procedures. 
• Ensure adequate training is developed, maintained and provided according to local needs to all users of the NC/CAPA process & systems. 
• Lead and coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third-party audit activities.

Qualifications Knowledge Skills

• BS in a science, engineering, business, or related discipline.
• 6+ years of experience within the medical devices, engineering, manufacturing, or related field required in a regulated industry.
• Strong Relationship, problem solving, continuous improvement, data management, and training skills.
• Expert working knowledge of regulatory requirements, standards, and regulations.
• Strong communication, influencing, and consensus-building skills.
• Experience in developing, implementing, and/or improving Quality System processes, procedures, and/or electronics systems.
• Working knowledge of, and experience with the following regulations/standards preferred:
  • 21 CFR Part 820
  • MDSAP
  • ISO standards (e.g., ISO 13485:2016, ISO 14971:2019)
• Good to have TrackWise.