Sr. CAPA / NC Specialist (Medical Device) - iMPact Business Group

Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. CAPA / NC Specialist for a 12 Month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

The Senior 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 Senior Specialist, CAPA will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues. Working within the QMS team, under general supervision, ensure compliance to CAPA processes and procedures.

RESPONSIBILITIES:

• 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. 
• 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 etc. 
• Subject Matter Expert on all related procedures, ensuring compliance to the relevant Corporate procedures. Super user of eCAPA system. 
• Lead & execute the NC/CAPA Review board forums. Lead multi-site forums and participate in global 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 achieved.
• Ensure adequate training is developed, maintained and provided to all users of CAPA process & systems
• 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 Internal, Corporate and third party compliance audits.

REQUIREMENTS:

• Bachelor's degree in science, engineering, or related subject required.
• Master's Degree in science or engineering preferred 
• Minimum of 4 years' experience in the area of quality systems in a regulated environment required. 
• Minimum of 4 years' experience in regulated environment (medical devices, automotive or aerospace) highly preferred. 
• Having a CAPA background; ownership of NC/CAPA preferred. 
• Strong knowledge of supporting Quality Systems (e.g. Audits, Management Review, Quality Planning) preferred

REQUIREMENTS:

• Bachelor's degree in science, engineering, or related subject required.
• Master's Degree in science or engineering preferred 
• Minimum of 4 years' experience in the area of quality systems in a regulated environment required. 
• Minimum of 4 years' experience in regulated environment (medical devices, automotive or aerospace) highly preferred. 
• Having a CAPA background; ownership of NC/CAPA preferred. 
• Strong knowledge of supporting Quality Systems (e.g. Audits, Management Review, Quality Planning) preferred