Quality Assurance Compliance Engineer (Medical Devices)

Location: On-site in Chelmsford, Massachusetts; applicants must reside within a reasonable commuting distance. No relocation is offered.

Annual salary: $90,000–$110,000.

Company

hirify.global develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, serving healthcare, emergency medical, public safety, and military customers worldwide.

What you will do

• Review CAPA records for appropriate content and manage CAPA KPIs against objectives.
• Lead cross-functional teams through CAPA activities and continuously improve the CAPA process.
• Support CAPA Lead appraisals, training, expectations, and development.
• Coordinate internal audits, monitor finding response timelines, and support timely closure of audit responses.
• Participate in external audits and support timely quality system and SOP compliance reviews.
• Assist with health risk assessments, regulatory correspondence, and Quality Management System training requirements.

Requirements

• Four-year degree.
• At least five years of related experience in a regulated environment, preferably medical devices.
• Experience with FDA QSR, ISO 13485, MDD, MDR, MDSAP, and ISO 14971.
• Proficiency with auditing techniques, time management, and project management.
• Excellent written, verbal, and interpersonal communication skills.
• Must be able to work on-site in Chelmsford, MA and must not require immigration sponsorship now or in the future.

Culture & Benefits

• Work focused on improving outcomes for patients with critical cardiopulmonary conditions.
• Culture emphasizing innovation, self-motivation, and an entrepreneurial spirit.
• Comprehensive benefits plans.
• Applications are accepted on an ongoing basis until the position is filled.