Quality Engineer II (Medical Devices)

Location: Beverly, Massachusetts, United States

Salary: $87,000–$105,000 annually, depending on skills, experience, and qualifications.

Company

hirify.global develops and manufactures medical device products in a regulated manufacturing environment.

What you will do

• Apply quality standards to product development, qualification, manufacturing, and acceptance decisions.
• Analyze data using statistical tools to improve process capability and support lean and continuous improvement initiatives.
• Lead Measurement System Analysis, metrology, product acceptance, and quality inspection activities.
• Create Master Validation Plans, IQ/OQ/PQ protocols and reports, quality design review deliverables, risk management plans, and quality documentation.
• Lead resolution of nonconformances, complaints, CAPAs, and other quality issues.
• Lead NPI quality and design transfer activities, including design verification, process validation, FMEA, supplier quality, and audits.

Requirements

• Bachelor’s degree in Engineering, Chemistry, Biology, or a related science or technical field.
• 3+ years of experience in medical devices or a related regulated industry.
• Experience with statistical methods, process control, audits, DOE, FMEA, Control Plans, MSA, SPC, GD&T, and fixturing.
• Experience in manufacturing metrology and quality inspection using Micro-Vu and Keyence measurement systems.
• Understanding of ISO 13485, ISO 14001, ISO 14971, GMP principles, and United States 21 CFR 820 requirements.
• Strong communication, cross-functional collaboration, problem-solving, critical-thinking, and deductive skills.

Culture & Benefits

• Full-time employment with hirify.global LLC.
• Equal opportunity workplace committed to diversity and inclusion.
• Regular collaboration with Quality, Engineering, Operations, Regulatory, customers, and suppliers.