Quality Engineer - ISO 13485 Mfg - Sturbridge, MA

Michael Page; Sturbridge (MA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Career growth opportunities

Job summary

Michael Page is seeking a Quality Engineer to provide hands-on support for medical device manufacturing, ensuring compliance with quality systems, regulatory and customer requirements. You will lead process improvement, validation, CAPA, risk management, inspections, and product transfer activities while partnering with engineering, operations, suppliers and customers.

The role offers a highly regulated, quality-driven environment with opportunities to impact products and processes, along with

Qualifications

• Bachelor's degree in Engineering or related field, or 2-5 years of Quality Engineering experience.
• 2-5 years of experience in medical device or regulated manufacturing.
• Working knowledge of ISO 13485, FDA regulations, MDSAP, ISO 14971, and QSR.
• Strong understanding of quality engineering tools, statistical methods, and problem-solving techniques.
• Experience with CAPA, risk management, FMEA, Control Plans, process validation, and quality systems.
• Strong communication and cross-functional collaboration skills.
• Proficiency with Microsoft Office and Minitab.
• Ability to manage multiple priorities while maintaining accuracy and accountability.
• Willingness to travel less than 10%.

Responsibilities

• Support QMS, FDA, ISO, and regulatory requirements across manufacturing operations.
• Support regulatory inspections, audits, investigations, and quality inquiries.
• Monitor production and ensure compliance with DMRs, procedures, and quality requirements.
• Lead product and process improvement initiatives using quality engineering methodologies.
• Review BOMs, drawings, specifications, FMEAs, Control Plans, and related changes.
• Lead risk analysis, test method validations, protocols, and technical reports.
• Coordinate process validations, capability studies, and statistical quality activities.
• Develop and implement incoming, in-process, and final inspection procedures.
• Manage nonconforming materials, corrective actions, and complaint investigations.
• Lead plant CAPA activities, including data analysis, trending, and root‑cause investigations.
• Support product transfers and new product introductions.
• Partner with suppliers, engineers, manufacturing, and customers to resolve quality issues.
• Develop Quality Plans covering inspection, testing, and gauge requirements.
• Provide work direction to Quality Inspectors and Technicians as needed.

Skills

Quality engineering

Statistical methods

Problem solving

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Tools

Minitab

MS Office

Job description

This Quality Engineer role provides hands‑on support for medical device manufacturing, ensuring products and processes meet quality system, regulatory, and customer requirements. The role leads process improvement, validation, CAPA, risk management, inspections, quality planning, and product transfer activities while partnering closely with engineering, operations, suppliers, and customers.

The company is a well‑established medical device manufacturer that provides a highly regulated, quality‑driven environment with opportunities to make a direct impact on products and manufacturing processes. Employees benefit from a collaborative culture, professional growth opportunities, competitive compensation, and comprehensive benefits.

Description

• Support QMS, FDA, ISO, and other regulatory requirements across manufacturing operations.
• Support regulatory inspections, audits, investigations, and quality inquiries.
• Monitor production and ensure compliance with DMRs, procedures, and quality requirements.
• Lead product and process improvement initiatives using quality engineering methodologies.
• Review BOMs, drawings, specifications, FMEAs, Control Plans, and related changes.
• Lead risk analysis, test method validations, protocols, and technical reports.
• Coordinate process validations, capability studies, and statistical quality activities.
• Develop and implement incoming, in-process, and final inspection procedures.
• Manage nonconforming materials, corrective actions, and complaint investigations.
• Lead plant CAPA activities, including data analysis, trending, and root‑cause investigations.
• Support product transfers and new product introductions.
• Partner with suppliers, engineers, manufacturing, and customers to resolve quality issues.
• Develop Quality Plans covering inspection, testing, and gauge requirements.
• Provide work direction to Quality Inspectors and Technicians as needed.

Profile

• Bachelor's degree in Engineering or a related field, or 2-5 years of Quality Engineering experience in a regulated industry.
• 2-5 years of experience in medical device or regulated manufacturing.
• Working knowledge of ISO 13485, FDA regulations, MDSAP, ISO 14971, and QSR.
• Strong understanding of quality engineering tools, statistical methods, and problem‑solving techniques.
• Experience with CAPA, risk management, FMEA, Control Plans, process validation, and quality systems.
• Strong communication and cross‑functional collaboration skills.
• Proficiency with Microsoft Office and Minitab.
• Ability to manage multiple priorities while maintaining accuracy and accountability.
• Willingness to travel less than 10%.

Job Offer

• Competitive $70K-$95K salary range
• Medical, dental & vision coverage from day one
• 401(k) and generous PTO plus 10 paid holidays
• Strong opportunities for career growth and advancement
• Hands‑on ownership of quality, validation, CAPA, and process improvement
  

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.