Sr. Staff Specialist NC CAPA

Position Summary:

The Senior Staff Specialist, NC/CAPA will be primarily responsible for the strategic development of the NC/CAPA process and procedures in accordance with relevant regulatory requirements for medical devices and Corporate NC/CAPA process and procedures.

The Senior Staff Specialist, NC/CAPA will provide technical leadership, through expertise in problem solving methodology, to facilitate proactive and effective resolution of issues.

The Senior Staff Specialist, NC/CAPA will be responsible for identifying and implementing significant systemic improvements, provide oversight to NC/CAPA owners and NC/CAPA specialists to ensure accountability and monitor processes for efficiency, effectiveness, and compliance related to global Stryker NC/CAPA process and procedures.

Essential Duties & Responsibilities: (Detailed Description)

• 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 NC/CAPA documentation changes and extension requests.
• Liaise with relevant functional groups, facilitate and guide teams through all stages of the NC/CAPA process.
• Support and coaching of the NC and CAPA teams regarding the application of NC/CAPA global Stryker ERP system eCAPA.
• Contribute to development of optimum future state of the NC/CAPA process for business needs in alignment with corporate direction.
• 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.).
• As a problem-solving methodology expert, leads and guides NC and CAPA teams in the application of problem-solving techniques and will promote their use and development, e.g., human error reduction, 4Ds, etc.
• "Act as a subject matter expert on all NC/CAPA related procedures, ensuring compliance to the relevant procedures and serve as eCAPA super-user.
• Knowledge of all procedures related to one’s own activity and ensuring that relevant company procedures are followed.
• Furthermore, being the NC/CAPA Process Owner ensuring compliance to the relevant standards and regulations, Corporate and local procedures.
• Provides review and futuristic 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.
• "Deliver on the job training and coach new eCAPA users and certify new NC/ CAPA specialists on NC/ CAPA principles and on the system as certified NC/CAPA specialist trainer.  
• Through Global Corporate teams, give input to the development and maintenance of training for users of CAPA process & systems. "
• 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-site and global project teams in areas of NC & CAPA.
• Lead and coordinate preparation, participation and follow-up for Stryker internal, Corporate, and third-party audit activities.
• Ensure compliance to NC/ CAPA processes and procedures.
• May act as designee for Franchise Quality System Manager, CAPA in appropriate situations. 

Education & Special Trainings:

• Bachelor’s Degree – United States of America & Ireland
• EQF Level 6 or equivalent – EU
• Masters / PhD advantageous (EQF Level 7 or 8 advantageous)

Qualifications & Experience:

• Minimum 6 years’ experience in a Quality/Regulatory Affairs function
• Profound knowledge and understanding of US, European and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired)
• Profound knowledge of supporting Quality Systems (e.g. Audits, Management review, Quality Planning).
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required
• Develops strong relationships, problem solving, drives organizational change, strategizes data governance and analytics, and actively promotes and engages in self-development.
• Sets and achieves personal goals, inspires and motivates others, optimizes task management for efficiency and balances complex and competing priorities.
• Advises on regulatory compliance, integrates standards into organizational processes, and manages regulatory compliance programs.
• Communicates complex ideas effectively, drives change through effective influencing and can resolves conflicts and builds broad agreement.
• Leads virtual teams effectively and leads cross-functional teams to achieve goals.
• Influences executive decision-making, develops and implements communication strategies with team members and leads cross-functional initiatives.
• Develops complex data models for insights and implements strategic actions based on data.
• High level of PC skills required. 
• Fluent in written and oral English - B2 Level (writing documents, meeting minutes, conference calls, etc.)
• Some travel may be required