Quality Engineer - Medical Devices - Franklin, MA

The Quality Engineer, Medical Device Manufacturing, will lead efforts to ensure product quality and compliance by developing and implementing quality processes, investigating non-conformities, and driving continuous improvement initiatives. This role requires a hands-on approach, working closely with manufacturing, engineering, customers, and suppliers to uphold the company's quality standards.

Client Details

My client is a growing contract manufacturer specializing in high-precision components for the medical industry. They provide advanced manufacturing capabilities, including CNC grinding, Swiss turning, deep-hole drilling, and catheter processing. Their operations span multiple facilities, supporting a range of medical markets, including orthopedics, interventional therapies, and minimally invasive surgery. The company has expanded significantly in recent years and continues to invest in innovation and process excellence. They are based out of Franklin, MA.

Description

The Quality Engineer, Medical Device Manufacturing, will:

• Develop and implement quality policies, procedures, and compliance initiatives
• Lead investigations into non-conformances, customer complaints, and CAPAs
• Support manufacturing process validation and product qualification efforts
• Manage change control and supplier/customer quality notifications
• Define and oversee inspection and testing requirements for production
• Analyze production data, customer feedback, and scrap rates to drive improvements
• Conduct internal audits to ensure ongoing ISO 13485 compliance
• Collaborate with cross-functional teams to enhance quality processes
• Train and mentor staff on quality-related best practices
• Work closely with customers and suppliers to resolve quality concerns
• Support continuous improvement projects using Lean methodologies
• Onsite at our Franklin, MA facility

Profile

• Proven experience in quality control / quality engineering within a regulated manufacturing environment (medical device preferred)
• Strong analytical skills with the ability to investigate and resolve quality issues
• Hands-on experience managing CAPAs and driving corrective actions
• Customer-facing experience, with strong communication and problem-solving abilities
• Working knowledge of ISO 13485 and quality system compliance
• Ability to define and implement in-process and incoming inspection requirements
• Experience with risk analysis techniques, including PFMEA
• Proficiency in blueprint reading, including GD&T
• Familiarity with measurement tools such as optical comparators and micrometers
• Project management skills with the ability to manage multiple initiatives
• Experience with quality software tools, including Microsoft Office and ERP/MES systems
• Positive attitude and ability to work in a fast-paced, collaborative environment
• Local to Franklin, MA

Job Offer

• Comprehensive benefits package, including healthcare, retirement plans, and paid time off
• Career growth within a fast-growing, quality-driven organization
• Opportunity to work with cutting-edge manufacturing technologies
• Collaborative team environment with strong leadership support

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.