Product Quality Assurance Engineer (Medical Devices)

Location: Hybrid role in Chelmsford, MA; applicants must reside within a reasonable commuting distance. The role does not offer relocation.

Salary: $82,400–$90,000 annual salary.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, serving EMS, hospital, public safety, and military customers globally.

What you will do

• Support product and complaint investigations through data gathering, product failure analysis, and root cause analysis.
• Support product risk management, including risk assessments, documentation updates, and maintenance of risk management files.
• Analyze complaint, service, and field performance data to identify trends and product quality improvement opportunities.
• Support CAPA and nonconformance activities, including documentation, tracking, and follow-up.
• Participate in design reviews, quality assessments, and design verification and validation quality activities.
• Collaborate with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams while maintaining compliant quality records.

Requirements

• Bachelor's degree in Engineering or a related technical discipline.
• 2+ years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry.
• Internship, co-op, or early-career experience in medical devices, manufacturing, or a regulated industry.
• Basic understanding of engineering principles, data analysis, and problem-solving techniques.
• Strong organizational skills and attention to detail, including the ability to manage documentation and follow established processes.
• Ability to collaborate in cross-functional teams and communicate findings clearly to technical stakeholders.
• Familiarity with complaint handling, CAPA, nonconformance systems, or risk management processes.
• Exposure to medical device design controls, verification and validation, or post-market quality activities.
• Advanced English proficiency required.

Nice to have

• Experience using quality system tools or data analysis tools.
• Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971.

Culture & Benefits

• Hybrid/remote collaboration with occasional travel for team meetings, training, investigations, audits, or site support.
• Work effectively in a remote environment while collaborating across teams and time zones.
• Culture values innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits plans are available.
• Physical demands include occasional standing, walking, talking, and hearing; constant sitting and frequent repetitive motions.
• hirify.global does not provide immigration-related sponsorship; applicants must not require current or future H1B, TN, STEM, OPT, or other hirify.global immigration sponsorship.

Hiring process

• Applications are accepted on an ongoing basis until the position is filled.