Quality Engineer- Medical Device- Chelmsford, Ma

This Quality Engineer role focuses on hands-on support for manufacturing engineering, addressing non-conformances, implementing CAPAs, managing supplier quality, conducting audits, and executing QMS processes.

Client Details

The company headquartered in Nashua, New Hampshire, specializes in advanced micro-manufacturing for the medical device industry, offering services such as laser processing, nitinol shaping, photochemical machining, and fiber optic sensing. With a global presence, including facilities in the U.S., Canada, Costa Rica, Israel, and Switzerland, the company provides rapid prototyping and scalable production solutions for complex medical devices, particularly in interventional cardiology, neurovascular, and structural heart applications.

Description

• Lead cross-functional teams to implement robust systems and controls, ensuring defect-free products that meet business objectives and customer expectations.

• Drive compliance with 21 CFR 820 and ISO 13485 by influencing change and ensuring understanding across teams.

• Participate in continuous improvement and process validation activities using tools like DOE, FMEA, Quality Plans, Gage R&R, and other quality tools.

• Analyze unique and adverse situations, gather information from diverse functional areas, and make appropriate quality recommendations based on facts.

• Review and approve protocols, validation documents, investigations, and procedures.

• Support investigations and assist in data and information collection as required for quality events.

• Serve as a subject matter expert during FDA and other government agency site inspections.

• Develop process and quality procedures.

• Implement continuous improvement methodologies and metrics in cells to improve business metrics.

• Act as the customer liaison for all quality-related issues.

• Mentor and train other engineers/technicians in quality methodologies and regulatory requirements.

• Support equipment calibration and maintenance per applicable procedures, maintaining accurate calibration records in accordance with internal requirements.

• Proactively develop improvement ideas based on experienced assessment of departmental and company performance.

• Represent quality in project team meetings and on assigned projects.

Profile

• Experience in Quality Engineering within the medical device industry or a startup environment.

• Hands-on experience in a manufacturing setting, ensuring product quality and process efficiency.

• Proven ability to communicate effectively, both in writing and verbally, with cross-functional teams and stakeholders.

• Strong project management skills, with a keen eye for detail to drive initiatives to successful completion.

• Proficiency in statistical analysis tools, including Minitab, to interpret data and support decision-making.

• Bachelor's degree in Engineering or a related technical field, or equivalent practical experience.

Job Offer

Compensation & Benefits

• Annual Profit Sharing Bonus: Eligible employees receive a profit-sharing bonus ranging from 3% to 4% of their annual salary, disbursed each year.

• Team Engagement: The company fosters a collaborative and supportive work environment, characterized by high performance and mutual assistance among team members.

• Monthly Team Lunches: Employees gather monthly for team lunches, providing opportunities for social interaction and team bonding.

• Leadership & Corporate Relations: The organization is led by experienced professionals who maintain strong connections with corporate leadership, ensuring alignment with company goals.

• Summer Activities: Employees can participate in various summer events, including food trucks, bounce houses, and axe throwing, promoting team cohesion and relaxation.

• Holiday Celebrations: The company organizes annual holiday parties to celebrate achievements and foster a sense of community.

• Comprehensive Benefits Package: Employees have access to a range of benefits, supporting their health, well-being, and work-life balance.

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.