Quality Engineering Program Manager (Post Market), Santa Rosa, CA or Galway, IRE
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.Responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product
Responsible for Design Assurance activities supporting changes to commercial products.
Mentor team members through technical problem solving including CAPA investigations and triaging issues.
Provide technical knowledge and input into risk assessments when quality issues are being evaluated.
Provide front room support during inspections from regulatory agencies (e.g. FDA, FDB, Notified Body).
Demonstrate the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management.
Create strategic plans for driving efficiencies, improving competencies, and developing people to continuously improve function.
Provide oversight and expertise in design change control and risk management activities.
Must Have: Minimum Requirements: To be considered for this role, please ensure the minimum requirements are evident on your resume.
Requires a Bachelor's Degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
Nice to Have:
7+ years relevant engineering experience with implantable medical products
Master’s degree in engineering, science, or business
Working knowledge of multiple quality disciplines, especially reliability, safety and compliance
Quality or reliability engineering experience in product development
Knowledge and experience of product development processes and design controls
Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or loca
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