Sr Prin Quality Engineer

* Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.
* Collaborate with cross-functional teams, including R&D, manufacturing, NPD and regulatory affairs, to define and implement systems engineering processes that ensure product quality and compliance throughout the product lifecycle.
* Ensure compliance with all relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections.
* Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure that products meet specified requirements.
* Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports.
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* Education:

** Bachelor’s degree in Engineering, or a related technical field. Advanced degree preferred.
** Regulatory Knowledge:
** In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
** Problem-Solving:
** Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
** Communication:
** Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
** Leadership:
** Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.
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* Experience:

** Experience in Quality Assurance, Engineering, Capital equipment
** Industry

Experience:

** Medical device industry.
** Technical

Skills:

** Proficient in quality assurance practices, risk management, and regulatory compliance.
** 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 insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple 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 match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital 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.

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 find  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.
* ** Build
* * a better future, amplifying your impact on the causes that matter to you and the world
* ** Grow
* * a career reflective of your passion and abilities
* ** Connect
* * to a dynamic and inclusive culture that welcomes the challenge of life-long…