Quality Engineer
3B Staffing LLC
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.
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.
Vacancy posted 3 days ago
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