Quality Engineer / Quality Systems Specialist

Role overview

This contract opportunity is for an experienced Quality Engineer / Quality Systems Specialist based in Durham, NC. The assignment is intended to be long term and supports a busy medical device manufacturing setting that operates under FDA regulations. The main objective of the role is to strengthen quality systems, close quality backlogs, and keep the site aligned with regulatory and internal requirements.

What you will do

• Own and progress CAPAs and non-conformance investigations through to closure in a timely manner.
• Assist with complaint processing, audit preparation, and risk management work.
• Carry out root cause analysis and put effective corrective and preventive measures in place.
• Help ensure adherence to FDA rules, ISO 13485, and internal quality system standards.
• Work closely with Manufacturing, Engineering, and Quality functions to address quality-related issues.
• Contribute to continuous improvement efforts and keep quality system records and documentation current.

What we are looking for

• Background in Quality Engineering or Quality Systems within the medical device sector.
• Practical experience handling CAPA, non-conformances, complaints, audits, and risk management activities.
• Solid working knowledge of FDA Quality System Regulation 21 CFR Part 820 and ISO 13485.
• Demonstrated ability to investigate issues and determine root causes.
• Strong problem-solving ability along with clear communication and documentation skills.

Additional information

This role was shared by a recruiting manager on behalf of a client. The assignment is for a contract position in Durham, NC, with a long-term duration.

The hiring team is actively building a pipeline of professionals for both immediate and future openings. Candidates are asked to share an updated resume and provide the best phone number and time to connect if interested.

Employer contact details and company address were included in the source.