Senior Quality Systems Manager, Design Quality Center of Expertise
Senior Quality Systems Manager, Design Quality Center of Expertise
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Job Description
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
The Senior Quality Systems Manager drives the evolution of Medtronics product development processes to set new industry-leading standards serving as a domain expert in Design Control. Lead our team by coaching internal customers across our diverse product portfolio to elevate Design Control capabilities throughout the this role you will proactively identify and implement large-scale initiatives that enhance rigor productivity and user experience by leveraging cutting-edge technologies and innovative methodologies.This is an on-site position that requires candidates to work in the Mounds View MN Lafayette CO Boston MA Memphis TN or Santa Rosa CA office 4-days per week minimum.
Responsibilities may include the following and other duties may be assigned.
- Lead enterprise-wide initiatives with emphasis on Design Reliability & Manufacturability (DRM) to ensure product quality regulatory compliance and operational excellence across all Medtronic Operating Units (OU).
- Apply your technical expertise to Put Patients First every day
- Apply Design for Reliability and Design for Manufacturability principles to reduce risk improve First Time Quality (FTQ) and enable efficient design transfer.
- Guide cross-functional teams through the Product Development Process (PDP) with a strong focus on positive design control outcomes and regulatory adherence.
- Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS) ensuring field performance insights are incorporated into early design phases.
- Apply systems engineering principles to coordinate complex multi-disciplinary product development efforts from concept through commercialization.
- Leverage biomedical engineering knowledge to ensure designs meet functional safety and efficacy requirements in compliance with medical device standards.
- Maintain deep familiarity with FDA 21 CFR Part 820 ISO 13485 and other design-controlled regulations providing expert guidance on compliance throughout the development lifecycle.
- Partner closely with R&D and Quality colleagues to embed best practices in technical rigor simplify execution and bring forward individual perspectives that strengthen decision-making and solution design.
Must Have: Minimum Requirements
To be considered for this role please ensure the minimum requirements are evident in your applicant profile.
Bachelors Degree with 7 years of work experience in Quality with 5 years of managerial experience
OR Advanced Degree with 5 years of work experience in Quality with 5 years of managerial experience
Nice to Have: Preferred Qualifications
Experience leading complex projects/programs
Experience with SPC CAPA NCMR PDP processes
Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously
Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization
PMP Certification
Working knowledge of Quality System Regulations such as (QSR 21 CFR 820) and ISO 13485:2016
Manufacturing Experience
Green Belt Six Sigma/DRM Training/Certification
Effective verbal and written communication analyticalinfluencing and interpersonal skills
Demonstrated working knowledge of process validation statistical methods risk management
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
Employment Type
Full-Time
