QE II, MA

Quality Engineer II
Location: Devens, MA
Industry: CDMO - Medical Device

We are thrilled to announce an exciting opportunity for a Quality Engineer II with a leading CDMO specializing in both Medical Device and Pharma products. With over 30 years of industry experience, this company offers a dynamic and fast-growing environment with significant opportunities for career advancement. Based at their Devens, MA facility, this role will allow you to work on diverse and complex healthcare product pipelines, ensuring the highest quality standards are met across all phases of production.

Key Responsibilities:

• Create and maintain essential quality documentation such as pFMEAs, Control Plans, and IQ/OQ/PQ protocols.

• Lead customer complaint investigations and manage CAPA processes.

• Ensure compliance by managing ECOs, conducting audits, and overseeing regulatory adherence to ISO 13485 and 21 CFR Part 820 standards.

• Conduct root-cause analyses, develop action plans, and ensure quality systems are aligned with customer requirements.

• Provide input during customer audits and lead training programs to uphold quality standards across the team.

Join us to contribute to an industry-leading company with a strong reputation for innovation and quality in healthcare product manufacturing. Reach out to Cloe Broad to explore this exciting opportunity!