Quality Engineer / Quality Systems Specialist
Stark Pharma Solutions Inc · Durham, NC · 6 days ago
On-siteQuality AssuranceContract
Key Responsibilities
- Manage and drive CAPAs and Non-Conformance investigations to timely closure.
- Support Complaint Handling, Audit Readiness, and Risk Management activities.
- Conduct root cause investigations and implement effective corrective and preventive actions.
- Ensure compliance with FDA regulations, ISO 13485, and internal Quality System requirements.
- Collaborate with Manufacturing, Engineering, and Quality teams to resolve quality issues.
- Support continuous improvement initiatives and maintain Quality Systems documentation.
Required Qualifications
- Experience in Quality Engineering or Quality Systems within the Medical Device industry.
- Hands-on experience with CAPA, Non-Conformances, Complaints, Audits, and Risk Management.
- Strong knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
- Prominent root cause analysis and investigation experience.
- Excellent problem-solving, communication, and documentation skills.
Benefits
Commensurate with experience.
Pay
TBD
Schedule
TBD
Qualifications
Commensurate with experience.
Skills
N/A
Job Title
Contract Quality Engineer / Quality Systems Specialist
Company
Stark Pharma Solutions Inc
Contact Information
Email: karthik@starkpharma.com
Address: 15 Corporate Place S, Suite 350, Piscataway, New Jersey 08854
Website: www.starkpharma.com