Senior Manager, RDQA (Medical Devices)

Location: Branchburg, New Jersey, United States

Salary: $124,500–$236,500 USD per year

Company

hirify.global develops medicines, medical devices, and combination-product solutions across therapeutic areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Provide quality-system guidance for medical device development, design controls, and change control.
• Assess product requirements, safety risk management, verification, validation, manufacturability, biocompatibility, sterilization, packaging, and reliability documentation.
• Partner with product and manufacturing engineering to translate design requirements into manufacturing requirements.
• Lead design, manufacturability, and reliability activities, including robust engineering, reliability prediction, capability analysis, CTQ development, VOC, and requirements flow-down.
• Provide quality oversight for clinical batch manufacturing, equipment qualification, process adherence, data traceability, and batch release.
• Support regulatory audits, inspections, CAPA investigations, quality harmonization, and continuous improvement initiatives.

Requirements

• 10+ years of experience in the medical device industry, including 2+ years in project management.
• Bachelor’s degree in engineering or a scientific discipline; a master’s degree is preferred.
• Strong knowledge of medical device development, design controls, quality risk management, FMEA, DOE, statistical process control, and CAPA.
• Expertise applying FDA 21 CFR Part 820, ISO 13485, ICH Q9, 21 CFR Part 4, ISO 14971, IEC/EN 62366, ANSI HE75, and other applicable medical device and combination-product standards.
• Experience with requirements analysis, reliability analysis, test methods, test method validation, technical report writing, and presentations.
• Experience working with regulatory agencies and notified bodies and influencing cross-functional and external partners.

Culture & Benefits

• Paid time off, vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility for long-term incentive programs.
• Work focused on innovation, quality improvement, and solutions for serious health issues.