Quality Manager I - Design Assurance
Marlborough, MA, US, 01752
Hiring Manager: Amie Lynn Preston
Recruiter: Spencer Gregory Hale
The Quality Manager I - Design Assurance provides leadership and guidance to the new product development and sustaining engineering teams with a focus on identifying and meeting the quality goals for the SUO portfolio within the Endoscopy division.
Your responsibilities will include:
- Manages and leads the quality engineering team by providing coaching, ongoing feedback, mentoring, training and ensuring employees receive development opportunities
- Collaborates with division partners to ensure product development project plans and resources are properly developed and maintained
- Coordinates the Design Assurance resource loading for the franchise’s Design Quality Assurance Sustaining and NPD activities
- Identifies opportunities for improvement of the Product Development Process and initiates activities to support the improvement process
- Participates in the development of the new products and processes, issues resolutions and design reviews participation
- Acts as an adviser to subordinates and may become actively involved, as required, to meet schedules and resolve problems
- Participates on teams, projects and assignments, facilitating or leading teams as necessary
- Provides guidance to test methods, equipment acquisition, sample plan definition, and validation development
- Participates in technical documentation of the international submissions
- Assures product and process adherence to applicable medical device and electrical safety standards
- Participates in internal and external audits
- Presents data to upper management related to departmental metrics and key project milestones
What we are looking for in you:
Minimum Qualifications:
- Bachelor's degree in engineering/technical discipline or equivalent
- Minimum of 7 years of experience in quality and/or design assurance work experience in a regulated industry
- Ability to travel up 15% (domestic and international)
Preferred Qualifications:
- Experience in the medical device industry
- In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management
- Previous BSC experience preferred
- Supervisory and performance management/coaching experience
- Electrical or systems experience a plus
Requisition ID: 541454
Nearest Major Market: Boston
Job Segment:
Quality Manager, Medical Device, QA, Quality Assurance, Surgery, Quality, Healthcare, Technology