Hi,
My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on CAPA Specialist position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows
Position: CAPA Specialist
Location: Durham, NC
Duration: Long-Term Contract
Job Overview
We are seeking an experienced CAPA Specialist to support quality system remediation activities within a medical device manufacturing environment. The ideal candidate will have strong expertise in CAPA, Non-Conformances, Audits, Complaints, and Risk Management, with the ability to independently drive quality initiatives and ensure regulatory compliance.
Key Responsibilities
- Lead and manage CAPAs, Non-Conformances, Complaints, and Audit activities through closure.
- Drive quality system remediation projects and implement sustainable process improvements.
- Develop, revise, and improve Risk Management procedures in compliance with FDA and ISO 13485 requirements.
- Review and remediate existing quality records using risk-based decision-making.
- Plan, conduct, and document internal and external audits.
- Perform root cause investigations and verify CAPA effectiveness.
- Collaborate with cross-functional teams to identify quality system gaps and implement corrective actions.
- Ensure timely completion of quality activities while maintaining compliance with regulatory standards.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- Experience in the Medical Device industry is required.
- Strong knowledge of CAPA, Non-Conformances, Complaints, Audits, and Risk Management.
- Experience supporting or leading Quality System remediation projects.
- Hands-on experience rewriting procedures and remediating quality records.
- Working knowledge of FDA 21 CFR Part 820/Part 820 QMSR and ISO 13485.
- Excellent problem-solving, documentation, and communication skills.
- Ability to work independently in a fast-paced, regulated environment.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/
Thank you,
Karthik Mutyala
Recruiting Manager
Stark Pharma Solutions Inc
Email: karthik@starkpharma.com
15 Corporate Place S, Suite 350,
Piscataway, New Jersey 08854
www.starkpharma.com