Senior Quality Engineer
Senior Quality Engineer
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$ 96800 - 145200
1 Vacancy
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 Engineer plays a critical role in ensuring the compliance robustness and effectiveness of the Quality Management System (QMS) in alignment with global regulatory requirements and internal policies. This individual will serve as a subject matter expert (SME) across multiple quality subsystems - such as CAPA Internal Audits Document Control and Training - supporting cross-functional teams and driving continuous improvement.
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.
Key Responsibilities:
Lead the maintenance execution and continuous improvement of core Quality System elements (e.g. CAPA NCR Change Control Document Management Audit Training).
Ensure QMS compliance with applicable regulations and standards (e.g. FDA 21 CFR 820 ISO 13485 EU MDR MDSAP CMDR).
Serve as Quality SME during internal/external audits (e.g. FDA Notified Bodies Corporate) supporting audit readiness walkthroughs and remediation efforts.
Author review and revise quality system procedures work instructions and policies to ensure clarity regulatory alignment and operational efficiency.
Drive and support cross-functional CAPA investigations root cause analysis (e.g. 5-Why Fishbone Fault Tree) effectiveness checks and timely closure of actions.
Monitor and report on Quality System health metrics identifying trends and opportunities for system-wide improvements during monthly reviews and quarterly Management Review.
Partner with functional owners to ensure timely training gap closure and system compliance across the organization.
Support QMS harmonization and integration efforts through evolving business needs and/or regulatory changes.
Mentor and coach junior quality team members and functional stakeholders on QMS best practices.
Minimum Qualifications:
Bachelors degree plus 4 years of experience in Quality or Engineering (or 2 years with an advanced degree).
Nice to Have:
Bachelors degree in Engineering Life Sciences or related field.
Experience in the medical device pharmaceutical or life sciences industry.
Strong working knowledge of FDA QSR ISO 13485 ISO 14971 EU MDR and MDSAP regulations.
Proven experience leading CAPA investigations internal audits or regulatory inspection preparation.
Excellent attention to detail organization and communication skills (verbal and written).
Ability to lead cross-functional teams and influence without authority.
Proficiency with electronic QMS platforms (e.g. Agile TrackWise or similar).
Certification in quality (e.g. ASQ CQE CQA or Lead Auditor).
Experience working in a multi-site global organization.
Familiarity with risk management files design controls or software validation is a plus.
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:
Senior IC
Employment Type
Full-Time
