Quality Engineer II (Medical Devices)

Location: Mystic, Connecticut, United States; onsite five days per week. No travel is required. Candidates must have unrestricted U.S. work authorization; sponsorship is not available for this role.

Salary: $79,200–$118,800 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and manufactures medical devices used to support patient care.

What you will do

• Support nonconformance investigations, root cause analysis, and corrective action implementation.
• Facilitate CAPA activities, including documentation, effectiveness verification, and closure.
• Maintain calibration programs and support calibration-related quality activities.
• Execute and document process and equipment validation activities, including IQ, OQ, and PQ.
• Collaborate with manufacturing and engineering teams to maintain product and process quality requirements.
• Analyze quality data, maintain quality records, and participate in audits, inspections, and regulatory readiness activities.

Requirements

• Bachelor’s degree with at least 2 years of relevant experience, or a master’s degree with no minimum experience requirement.
• Experience supporting quality system processes in a regulated manufacturing environment.
• Experience with nonconformance investigations, root cause analysis, and corrective actions.
• Working knowledge of quality documentation requirements and regulatory compliance standards.
• Ability to manage multiple projects while maintaining accurate and compliant documentation.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment.

Nice to have

• Medical device industry experience.
• Working knowledge of TrackWise quality management systems.
• Experience with SAP for quality, manufacturing, or calibration activities.
• Knowledge of calibration management and process or equipment validation.
• Strong analytical skills and experience driving process improvements.

Culture & Benefits

• Onsite collaboration with manufacturing, engineering, and operations teams.
• Health, dental, and vision insurance, with HSA and healthcare FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, short-term and long-term disability coverage, and life insurance.
• Tuition assistance, employee stock purchase plan, employee assistance program, and incentive plans.