Senior Quality Engineer (Medical Devices)

TL;DR

Senior Quality Engineer (Medical Devices): Supporting quality engineering across design transfer, manufacturing, inspections, validations, field returns, and quality data systems with an accent on FDA-regulated medical device and IVD manufacturing, risk management, and process control. Focus on analyzing quality trends, leading root-cause and corrective-action activities, validating processes and equipment, and improving plant-wide compliance and product yield.

Location: Hybrid work schedule on-site in Billerica, Massachusetts, 4–5 days per week on-site.

Salary: $125,000–$135,000 per year.

Company

hirify.global develops diagnostic and biotechnology instruments and solutions for clinical and biopharmaceutical markets, with FDA-registered and ISO-certified manufacturing operations.

What you will do

• Provide oversight and expertise across quality planning, inspection procedures, document control, change management, process controls, validations, audits, and corrective and preventive actions.
• Prepare and review Engineering Change Orders, Manufacturing Variances, operating procedures, and operating instructions.
• Maintain Quality Control Plans and PFMEAs for new and existing products and participate in Product Line Quality Committees.
• Design database queries and reports, analyze production and quality data, and identify trends for management reporting.
• Generate and review IQ, OQ, and PQ validation protocols and reports for equipment, processes, and test methods.
• Lead root-cause investigations, corrective actions, DHR reviews, and initiatives to improve yield, product quality, and regulatory compliance.

Requirements

• Bachelor’s degree or higher in engineering or a technical science, or equivalent experience.
• 8+ years of Quality Engineering experience in FDA-regulated medical device, IVD, or reagent manufacturing.
• Strong knowledge of ISO 13485, ISO 14971, MDSAP, and FDA 21 CFR Part 820 requirements.
• Experience with PFMEAs, risk analysis, validation plans, internal audits, inspection methods, sampling plans, statistical analysis, and SPC.
• Experience with Microsoft Word, Excel, Access, and statistical software such as Minitab; ability to interpret technical documents and collaborate with multidisciplinary teams.
• Ability to stand, walk, lift and carry up to 25–50 pounds, perform repetitive physical tasks, and use PPE in manufacturing environments.

Nice to have

• Experience with MasterControl or Power BI.
• ASQ certification as a Medical Device Auditor or Quality Engineer.
• Additional experience performing and reviewing manufacturing, quality equipment, process, or test method validations.

Culture & Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match, bonus program, generous PTO, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Collaborative, mission-driven environment focused on innovation, accountability, integrity, and global health impact.
• On-site office benefits include subsidized meals, lunch and snacks, depending on location.