Senior Quality Engineer (Medical Devices)

TL;DR

Senior Quality Engineer (Medical Devices): Supporting and improving quality systems across design transfer, inspection, production, validation, and data monitoring with an accent on FDA-regulated IVD and medical-device manufacturing, risk management, and compliance. Focus on leading quality initiatives, resolving root causes, validating processes and equipment, and driving continuous improvement across R&D and manufacturing.

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

Salary: $110,000–$130,000 per year.

Company

hirify.global develops medical, biotechnology, and in vitro diagnostic instruments for biopharmaceutical and clinical markets.

What you will do

• Provide oversight and continuous improvement for quality systems, including audits, document control, change management, CAPA, validations, and quality records.
• Lead quality initiatives, product-line quality committees, and quality planning for new product introductions.
• Prepare and review Engineering Change Orders, Manufacturing Variances, control plans, PFMEAs, specifications, and acceptance activities.
• Design and validate production, non-conformance, and CAPA database queries and reports; analyze trends and quality data.
• Generate and review IQ, OQ, and PQ validation protocols and reports while maintaining validation files and logs.
• Investigate root causes, define corrective actions, support audits, and communicate quality improvements to leadership and cross-functional teams.

Requirements

• Bachelor’s degree or higher in engineering or a technical science.
• 7+ years of medical-device or IVD quality-engineering experience, or 4+ years as a Senior Quality Engineer in an FDA-regulated manufacturing company.
• Knowledge of ISO 9001, ISO 13485, ISO 14971, IVDR, and FDA-regulated quality requirements.
• Strong communication, analytical, prioritization, documentation, judgment, and multitasking skills.
• Proficiency with Microsoft Word, Excel, Access, and statistical software such as Minitab.
• Ability to work in a laboratory environment, use PPE, handle equipment, and lift up to 25 pounds.

Nice to have

• Experience with MasterControl or Power BI.
• Auditing experience or certification.

Culture & Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match, bonus program, generous paid time off, and paid holidays.
• Tuition reimbursement and professional development opportunities.
• Hybrid and flexible work arrangements.
• Engagement events and subsidized food options at selected Massachusetts and Maine offices.
• Collaborative culture centered on customer focus, ingenuity, ownership, accountability, collaboration, and integrity.