Quality Engineer / Quality Systems Specialist

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Quality Engineer/Quality Systems 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: Contract Quality Engineer / Quality Systems Specialist

Location: Durham, NC

Duration: Long Term

Job Overview

We are seeking an experienced Quality Engineer / Quality Systems Specialist to support a fast-paced FDA-regulated medical device manufacturing environment. This role will focus on driving CAPAs, Non-Conformances, investigations, and Quality System improvements while helping reduce quality backlog and ensuring compliance with regulatory requirements.

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 .

Proven root cause analysis and investigation experience.

Excellent problem-solving, communication, and documentation skills.

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