Director, Quality Assurance & Regulatory - Framingham, MA

Framingham, Massachusetts Permanent USD160,000 - USD185,000 per year
  • Join a growing medical device manufacturer with innovative products!
  • Support treating atrial fibrillation with innovative technology & research

About Our Client

Our client specializes in providing healthcare professionals with advanced tools that enhance precision and control in treating complex medical conditions. They are dedicated to the science of innovative treatment technologies, focusing on creating durable and effective solutions. Their mission is to deliver exceptional patient care through customized solutions that optimize energy delivery across their product lines.

Job Description

  • Direct activities for the quality assurance group, supporting product development and sales with a focus on design controls.
  • Manage the quality function to ensure alignment with product development operations.
  • Participate in and manage external and internal audits, coordinating with auditing groups and internal stakeholders.
  • Support R&D engineering, manufacturing, and sustaining projects throughout the product life cycle.
  • Oversee the preparation, review, and approval of validation protocols, reports, risk analyses, and SOPs.
  • May assist in regulatory submissions.
  • Support operational and QA activities including complaint handling, non-conforming material disposition, CAPA, audits, calibration, document control, and training tracking
  • Lead by example to oversee and mentor direct reports in the quality department.
  • Strong knowledge of quality engineering tools and concepts.
  • Development, maintenance, and auditing of Quality Management Systems per ISO 13485, EU MDR, and FDA QSR.
  • Proficient in quality planning, data collection, charting, and statistical methods, including sampling.
  • Excellent organizational and problem-solving skills.



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.

The Successful Applicant

Core Competencies/Skills and Abilities Required

  • Lead by example to oversee and mentor direct reports in the quality department.
  • Strong knowledge of quality engineering tools and concepts.
  • Development, maintenance, and auditing of Quality Management Systems per ISO 13485, EU MDR, and FDA QSR.
  • Proficient in quality planning, data collection, charting, and statistical methods, including sampling.
  • Excellent organizational and problem-solving skills.
  • Strong interpersonal skills with the ability to interface well with all levels of employees.
  • Thorough and detail-oriented.
  • Excellent reading, writing, and communication skills in English.
  • Ability to work independently and collaboratively with minimal supervision.
  • Lead a team to achieve company goals.



Qualifications

  • Bachelor's degree (B.S.) or equivalent in a related field.
  • Minimum of 7 years of related experience in an FDA QSR, ISO 13485, and EU MDR compliant environment.
  • Extensive knowledge of quality engineering disciplines and Quality Systems development, maintenance, and auditing per ISO 13485, FDA QSR, and EU MDR.
  • Experience overseeing medical device quality departments, supplier management including sterilization suppliers, and interacting with EU MDR Economic Operators from quality and regulatory compliance perspectives.
  • FDA inspection and ISO audit hosting experience.
  • Experience with cardiac catheters and FDA/EU Class III medical devices is a strong plus.

What's on Offer

  • Comprehensive Health Benefits: Medical, dental, and vision insurance plans.
  • Financial Security: Competitive salary, 401(k) with company match, and life insurance.
  • Work-Life Balance: Paid time off, holidays, and flexible work schedules.
  • Professional Development: Opportunities for training, career advancement, and continued education.
  • Innovative Environment: Be part of a team working on cutting-edge medical technology.
  • Collaborative Culture: Work with talented professionals in a supportive and dynamic setting.
Contact
Isabel Reynes
Quote job ref
JN-052024-6440905

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Industrial / Manufacturing
Location
Framingham
Contract Type
Permanent
Consultant name
Isabel Reynes
Job Reference
JN-052024-6440905