Product Quality Engineer

Title: Product Quality Engineer Location: Medford, MA Experience: 3–5 Years

Duration: 12+ months

Key Responsibilities

Ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in manufacturing operations.

Perform inspections of incoming components, in-process materials, and finished products to verify compliance with specifications and quality standards.

Support product development teams by implementing design control processes, participating in design reviews, and ensuring quality requirements are met throughout the development cycle.

Maintain and review design history files (DHF), risk management documentation, and verification/validation activities in line with regulatory standards.

Investigate product complaints and non-conformances, conduct root cause analysis, and recommend corrective and preventive actions.

Collaborate with Engineering, Manufacturing, and Regulatory teams to address and resolve quality issues.

Conduct internal and supplier audits to ensure compliance with internal procedures and external regulations.

Track and report key quality metrics, trends, and performance indicators.

Contribute to continuous improvement initiatives and support CAPA processes.

Ensure compliance with applicable regulatory requirements, including ISO standards and FDA regulations.

Evaluate and qualify suppliers through audits and performance monitoring.

Perform additional duties as assigned by the company.

Minimum Qualifications

• Bachelor’s degree in Engineering or related discipline.

• 3–5 years of experience in manufacturing, quality control, or engineering within a regulated industry (medical devices, pharma, biotech, defense, aerospace).

• Experience working in cleanroom manufacturing environments.

• Hands-on experience with inspection and test equipment such as digital multimeters, micrometers, digital drop indicators, calipers, and oscilloscopes.

• Knowledge of auditing manufacturing and acceptance activities.

• Strong decision-making skills with keen attention to detail.

• Ability to work both independently and collaboratively within a team.

• Proficiency with basic computer applications.

• Solid understanding of regulatory requirements such as GMP, ISO 13485, and ISO 14971.

• Excellent written and verbal communication skills.

• Strong organizational, analytical, and critical thinking skills.

• Proven ability to manage multiple projects and meet deadlines.

• Results-driven and self-motivated with a fast-learning mindset.