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Stryker is hiring a Senior CAPA Specialist to join our Joint Replacement team in Mahwah, NJ. You will be primarily responsible for the oversight of the CAPA process and procedures, ensuring it is compliant, effective, and efficient in dealing with quality issues. The Senior CAPA Specialist will be responsible for problem-solving methodology and facilitating proactive and effective resolution of issues, ensuring compliance to CAPA processes and procedures.
What you will do
- Responsibility for review and approval of NC and CAPAs, with attention to detail, review for completeness, accuracy, effectivity, and timeliness.
- Liaise with relevant functional groups, facilitate and guide 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.
- Exhibit ability to build expertise in facilitating NC & CAPA teams in the application of problem-solving techniques and promote its use and development e.g. Human Error Reduction, 4-D etc.
- Highly proficient on NC/CAPA procedures, and super user of eCAPA system.
- Execute the NC/CAPA Review board forums.
- Monitor site NC/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums, ensure compliance to global requirements & metrics are achieved.
- Identify continuous improvement and collaboration opportunities.
- Participate in cross-plant and corporate project teams in areas of NC & CAPA.
- Coordinate in preparation, participate and follow up to Stryker Internal, Corporate and third-party compliance audits.
What you need
Required:
- Bachelor’s degree or higher in science, Engineering or applicable technical field.
- Minimum 3+ years’ experience working in a medical device or pharmaceutical regulated environment with 2+ years’ experience within NC/CAPA.
Preferred:
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).
- Ability to gain knowledge and understanding of US and International Medical Device Regulations.
- Experience in supporting Quality Systems (e.g. Audits, Management review, Quality Planning).
- Exhibit strong communication and influencing skills as well as have the ability to manage multiple tasks simultaneously.
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