Medtronic
Quality Engineering Program Manager (Post Market), Santa Rosa, CA or Galway, IRE
Medtronic, Santa Rosa, California, us, 95402
Quality Engineering Program Manager (Post Market), Santa Rosa, CA or Galway, IRE
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.
Across the Post-Market quality function, you will lead with speed and decisiveness to put patients first in everything we do. We’re committed to a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities
Lead product escalations across cross-functional groups
Monitor product performance, conduct complaint investigations, and evaluate quality issues impacting released products
Support design assurance activities for changes to commercial products
Mentor team members through technical problem solving, including CAPA investigations and issue triage
Provide technical input into risk assessments when quality issues are evaluated
Provide front-room support during inspections from regulatory agencies (e.g., FDA, Notified Bodies)
Communicate, influence, and negotiate with internal and external stakeholders to drive product quality improvements and post-market risk management
Create strategic plans to drive efficiencies, improve competencies, and develop people
Oversee design change control and risk management activities
Coordinate upstream/downstream communications for high-visibility issues
Required Qualifications
Bachelor’s degree and a minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience
Preferred Qualifications
7+ years of relevant engineering experience in the medical device industry
Master’s degree in engineering, science, or business
Experience with root cause analysis and leading technical investigations with cross-functional groups
Working knowledge of multiple quality disciplines, especially reliability, safety and compliance
Quality or reliability engineering experience in product development
Knowledge of product development processes and design controls
Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and drug-device combinations
Physical and Work Environment The statements describe the general nature and level of work being performed. They are not an exhaustive list of responsibilities and skills. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. For office roles, routine work involves computer use and collaboration with colleagues.
Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. A wide range of benefits, resources, and compensation plans are available to support you at every career and life stage. Salary ranges for U.S. locations: $140,800.00 – $211,200.00 (base, dependent on experience and location).
The following benefits and additional compensation are available to regular employees who work 20+ hours per week: health, dental and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability; dependent care spending account; tuition assistance/reimbursement; and well-being programs. Additional benefits include incentive plans, 401(k) with employer contribution and match, paid time off, paid holidays, Employee Stock Purchase Plan, and more.
Regular employees are not temporary. Some benefits may vary by location. Details are available from Medtronic’s benefits information. Medtronic is an equal employment opportunity employer. We will provide reasonable accommodations for qualified individuals with disabilities.
For more information about Medtronic’s business, mission, and commitment to diversity, please refer to our company information pages.
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Across the Post-Market quality function, you will lead with speed and decisiveness to put patients first in everything we do. We’re committed to a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Responsibilities
Lead product escalations across cross-functional groups
Monitor product performance, conduct complaint investigations, and evaluate quality issues impacting released products
Support design assurance activities for changes to commercial products
Mentor team members through technical problem solving, including CAPA investigations and issue triage
Provide technical input into risk assessments when quality issues are evaluated
Provide front-room support during inspections from regulatory agencies (e.g., FDA, Notified Bodies)
Communicate, influence, and negotiate with internal and external stakeholders to drive product quality improvements and post-market risk management
Create strategic plans to drive efficiencies, improve competencies, and develop people
Oversee design change control and risk management activities
Coordinate upstream/downstream communications for high-visibility issues
Required Qualifications
Bachelor’s degree and a minimum of 5 years of relevant experience, or an advanced degree with a minimum of 3 years of relevant experience
Preferred Qualifications
7+ years of relevant engineering experience in the medical device industry
Master’s degree in engineering, science, or business
Experience with root cause analysis and leading technical investigations with cross-functional groups
Working knowledge of multiple quality disciplines, especially reliability, safety and compliance
Quality or reliability engineering experience in product development
Knowledge of product development processes and design controls
Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and drug-device combinations
Physical and Work Environment The statements describe the general nature and level of work being performed. They are not an exhaustive list of responsibilities and skills. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. For office roles, routine work involves computer use and collaboration with colleagues.
Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. A wide range of benefits, resources, and compensation plans are available to support you at every career and life stage. Salary ranges for U.S. locations: $140,800.00 – $211,200.00 (base, dependent on experience and location).
The following benefits and additional compensation are available to regular employees who work 20+ hours per week: health, dental and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability; dependent care spending account; tuition assistance/reimbursement; and well-being programs. Additional benefits include incentive plans, 401(k) with employer contribution and match, paid time off, paid holidays, Employee Stock Purchase Plan, and more.
Regular employees are not temporary. Some benefits may vary by location. Details are available from Medtronic’s benefits information. Medtronic is an equal employment opportunity employer. We will provide reasonable accommodations for qualified individuals with disabilities.
For more information about Medtronic’s business, mission, and commitment to diversity, please refer to our company information pages.
#J-18808-Ljbffr