Sr. Quality Manager - Medical Device - Dedham, MA

This role involves implementing and maintaining quality systems aligned with regulatory requirements, ensuring compliance with ISO 9001 and GMP standards. Responsibilities include developing team capabilities, overseeing audits, driving process improvements, and maintaining regulatory compliance across the organization.

Client Details

A global leader in analytical instruments and services, the company specializes in innovative solutions for the biopharmaceutical, clinical, and food & beverage industries. Its diverse portfolio includes cutting-edge technologies for clonal isolation, micro-osmometers for GMP workflows, and tools that enhance efficiency and productivity in clinical labs worldwide.

Description

• Manage QA and QC teams to support organizational functions and ensure product quality.
• Lead Quality Management System (QMS) activities, including CAPA, NCMR, audits, and complaints.
• Coordinate global QMS processes to ensure consistency across multiple sites.
• Support new product development with compliance in requirements, specifications, and test protocols.
• Oversee product and process changes, ensuring risk management and regulatory compliance.
• Act as the QMS expert, staying updated on regulatory changes and industry standards.
• Drive a culture of quality and continuous improvement across the organization.

Profile

• Expert in ISO 13485, ISO 9001, FDA QSR, IVDR, and safety standards.
• 10+ years of quality systems experience in medical devices and in vitro diagnostics (IVD).
• 5+ years of leadership in team management and performance development.
• Proven success in managing ISO/MDSAP audits and regulatory inspections.
• Proficient in electronic QMS platforms and data-driven tools.
• Strong communicator with exceptional organizational skills.

Job Offer

Leadership Role: Directly manage and lead Quality Assurance (QA) and Quality Control (QC) teams, driving quality initiatives across the organization.

Strategic Impact: Lead and enhance the Quality Management System (QMS), including CAPA, audits, and compliance processes, shaping the overall quality strategy.

Global Exposure: Coordinate and align QMS activities with global teams, offering the chance to work across multiple sites and expand international experience.

Innovation and Development: Play a key role in new product development, ensuring regulatory compliance and quality throughout the process.

Continuous Improvement: Foster a strong culture of quality and continuous improvement, making a tangible impact on the organization's success.

Regulatory Expertise: Serve as the QMS expert, staying at the forefront of regulatory changes and industry best practices, advancing career expertise.

Career Growth: Opportunities for professional development in a dynamic, forward-thinking organization, with a focus on leadership and career advancement.

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.