CAPA Engineer
• Location: Sandy Springs, GA (Hybrid)
• Type: W2 contract (NO C2C OR THIRD PARTY)
• Length: until 05/2026 (Contract extension expectation)
• Pay Rate – $45 - $62 hourly
• Work Authorization - Must be able to work in the U.S. with approved authorization status.
A strong candidate will also have:
- Education - BA Degree in Science/Technical field or related field
- CAPA Experience
What You'll Do:
- 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 and is responsible to, but not limited to.
- 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.
- Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
- 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 Stryker Internal, Corporate and third party compliance audits.
Important information: To be immediately considered, please send an updated version of your resume to Danh704@kellyservices.com
*** (Kelly does not expense relocation/interview costs) **
In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:
• Competitive pay
• Paid holidays
• Year-end bonus program
• Recognition and incentive programs
• Access to continuing education via the Kelly Learning Center
