Sr. Quality Program Manager (Cardiac Electrophysiology)
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Job Location:
Mounds View, MN - USA
Monthly Salary:
$ 168800 - 253200
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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 -person exchanges are invaluable to our work. Were 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.Join Medtronic as aSenior Quality Program Manager Quality Core Team Member (QCTM)and be at the forefront of transforming lives through advanced medical this highly visible role you will serve as theQuality Core Team Memberfor complex cardiac electrophysiology programs working in close partnership with R&D Systems Engineering Manufacturing Regulatory Clinical and Operations to drive the successful development transfer and sustainment of Affera products.
By blendingtechnical qualityexpertiseprogram leadership and a deep commitment topatient safety regulatory compliance and design excellence you will play a critical role in ensuring robust design execution and highquality product delivery as Affera technology continues to scale globally.
Primary Responsibilities
Acts as theQuality Core Team Member (QCTM)andprogramlevel Quality leadfor assigned product development programs with accountability for quality strategy execution and outcomes across the full product lifecycle.
Plans directs and overseesall Quality aspects of design and development ensuring compliance with Medtronic policies global regulatory requirements and applicable quality system regulations.
Leads and integratesQuality program planning including design control strategy design verification planning risk management planning design transfer readiness and postmarket quality considerations.
Provides Quality leadership fordesign verification and validation activities including review and approval of test strategies protocols methods execution readiness and test results.
Ensuresrobust test method development qualification and validation partnering with engineering manufacturing and suppliers toestablishreliable reproducible and compliant methods.
Owns and drivesproduct and process risk management activities including hazard analysis FMEAs and risk/benefit assessments ensuring alignment with system architecture clinical intent and realworld use.
Leads Quality oversight fordesign transfer collaborating with manufacturing supplier quality operations and regulatory partners to ensure product and process readiness for commercialization.
Guides crossfunctional teams throughphase gate reviews design reviews and key quality decision points providing clear recommendations and riskbased decision support.
Monitors and ensures the integrity ofdesign history file (DHF) documentation traceability and configuration management throughout the development lifecycle.
Coordinates Quality activities withexternal suppliers test labs and consultants ensuringtimelydelivery compliance and risk mitigation.
Identifiesgaps risks and improvement opportunities within Quality processes and program execution; drives corrective actions and continuous improvement initiatives.
Is a mentorleaderor direct manager to earlier career QCTMs
Other duties may be assigned
Required Qualifications
Bachelors degree anda minimum of7years of relevant experience
ORanadvanceddegree witha minimum of5years of relevant experience
Preferred Qualifications
Experience working with Class IIImedical devices.
Broad knowledge ofQuality systems and product development with mastery in at least one technical or professional discipline and working knowledge across adjacent functions.
Proven experience leadingcrossfunctional matrixed teamson complex product development programs.
Strong understanding ofdesign controls design verification and validation risk management test methods and design transfer.
#LI-MDT
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 local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Manager
Key Skills
- Project Management Methodology
- Project / Program Management
- Program Management
- Management Experience
- Microsoft Powerpoint
- Project Management
- Microsoft Project
- Budgeting
- DoD Experience
- Leadership Experience
- Supervising Experience
- Contracts
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
