Quality Manager I - Design Assurance

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