Quality Engineer

Spectra Medical

Wilmington, MA

3+ Months

Job Description: Our client is seeking a Quality Engineer with experience in the medical device industry to support quality assurance and regulatory compliance efforts across product development and manufacturing. The ideal candidate will have a strong understanding of ISO 13485, FDA 21 CFR Part 820, risk management (ISO 14971), and other applicable quality standards and regulations.

Key Responsibilities:

• Support the development, implementation, and maintenance of quality systems in compliance with regulatory requirements.

• Strong experience and understanding of supplier controls.

• Conduct root cause analysis and implement corrective and preventive actions (CAPAs).

• Collaborate with cross-functional teams to ensure quality is built into product design and processes.

• Assist in the creation and review of quality documentation, including SOPs, protocols, and reports.

Education:

• Bachelor's degree in engineering, life sciences, or a related field.