Quality Manager - Medical Device Manufacturing - Bedford, MA

The Quality Manager, medical device manufacturing, will ensure products meet strict quality standards while driving continuous improvement to enhance reliability and performance. This role focuses on optimizing operational efficiency and implementing technical solutions to deliver high-quality products on time at our Bedford, MA facility.

Client Details

My client is an innovative company specializing in the design and manufacturing of advanced cell sorting technologies for cell therapy and industrial applications. Based in the Massachusetts technology corridor, with additional R&D teams in Texas and New Zealand, they are a leader in industrial-scale cell sorting, processing approximately one trillion cells daily across multiple countries.

The company operates under a robust quality management system that complies with ISO 9001:2015 and ISO 13485:2016, ensuring high standards for product performance and reliability. With state-of-the-art facilities, including an ISO 8 cleanroom for GMP consumable manufacturing and biological laboratory spaces, the company is committed to advancing cellular processing and supporting the growing cell therapy sector. The team continues to expand its capabilities, notably through strategic acquisitions like Verity Software House, which enhances their software expertise in cytometry.

Description

The Quality Manager, Medical Device Manufacturing will:

• Develop and implement a quality strategy aligned with company objectives, driving continuous improvement and operational efficiency.
• Manage the quality management system, including ISO 9001 re-certification and internal/external audits.
• Lead operations to ensure products meet quality requirements, customer expectations, and on-time delivery.
• Monitor key quality and operational performance metrics, using data to drive improvements and support scalability.
• Collaborate with supply chain and procurement teams to establish and maintain supplier quality standards.
• Ensure regulatory compliance with relevant standards (e.g., FDA, ISO, CE) across all quality processes.
• Implement risk management practices throughout the product lifecycle to identify and mitigate potential risks.
• Oversee supplier quality audits and inspections to ensure compliance with all applicable regulations.
• Promote Lean and Six Sigma methodologies to foster continuous improvement and proactive problem-solving.
• Work with Engineering to drive design and process improvements that enhance product quality.
• Communicate quality goals, progress, and challenges to senior leadership and cross-functional teams.
• Ensure finished goods meet product requirements before shipment.

Profile

• ISO 9001 & 13485 certification, with experience leading audits
• Proven ability to lead and improve quality systems
• Strong understanding of inspection requirements and processes
• Experience working cross-functionally with manufacturing and R&D teams
• Ability to collaborate effectively and foster cooperation across departments
• Management experience, overseeing quality inspectors and engineers
• Experience in a medical device company (preferred over aerospace/space)
• Ability to manage and drive quality improvements without disrupting workflows
• Knowledge of industry-specific regulations and compliance standards
• Skilled in problem-solving and implementing corrective actions
• Strong communication and interpersonal skills
• Ability to mentor and develop a small team
• Local to Bedford, MA

Apply today for consideration of your resume within 48 business hours!

Job Offer

What's on Offer:

• Comprehensive benefits package including medical, dental, and vision coverage
• Life insurance and 401k with company matching
• Paid time off and parental leave
• Access to corporate wellness programs
• Eligibility for all benefits on the first day of employment
• Dynamic, entrepreneurial work environment encouraging creativity and innovation
• Opportunities to contribute to a motivated, success-driven team

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.