Senior Supplier Quality Engineer
Job Location:
Irvine, CA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain restore health and extend life. Our 95000 employees work across more than 150 countries to put patients first developing innovative medical technologies that improve the lives of 72 million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose growth and impact.
This position is based in Irvine California and supports manufacturing research and development operations quality and sourcing teams within the Neurovascular business. The role is onsite five days per week and requires collaboration with internal stakeholders and external suppliers to support supplier qualification performance monitoring new product introductions and process improvements. Travel to supplier locations may be required for audits assessments and supplier development activities.
As a Supplier Quality Engineer you will partner with suppliers and cross-functional teams to ensure purchased materials and components meet quality and regulatory requirements throughout the product lifecycle. This role supports supplier qualification new product development activities supplier performance improvement and investigation of supplier-related quality issues that could impact product performance manufacturing operations or patient outcomes.
Lead supplier qualification and onboarding activities including quality assessments audits documentation review and approval of new suppliers.
Drive investigation root cause analysis and resolution of supplier-related nonconformances complaints and material quality issues.
Partner with Research and Development Manufacturing Operations Quality and Sourcing teams to support new product introductions design changes and supplier transfers.
Monitor supplier quality performance using established metrics and drive corrective and preventive actions to improve quality delivery and reliability.
Support risk management activities for supplied materials components and manufacturing processes including risk assessments and mitigation plans.
Collaborate with engineering teams to develop inspection strategies control plans test methods and qualification requirements for new products and components.
Conduct supplier audits and assessments to evaluate compliance with quality system regulatory and operational requirements.
Support validation qualification and continuous improvement activities at supplier sites to ensure consistent product quality and process performance.
Bachelors degree and 4 years of relevant experience Masters degree and 2 years of relevant experience or PhD.
Experience in supplier quality quality engineering manufacturing quality or a related quality-focused engineering function.
Experience leading investigations root cause analysis and corrective action activities for quality issues.
Experience working within a regulated quality management system and applying quality and compliance requirements.
Experience collaborating with cross-functional teams and external suppliers to resolve quality and process issues.
Experience in the medical device industry or other highly regulated industries operating under applicable regulatory and quality standards.
Experience supporting new product development design transfer supplier development or supplier qualification activities.
Experience conducting supplier audits and implementing supplier corrective action or corrective and preventive action programs.
Knowledge of Advanced Product Quality Planning (APQP) Production Part Approval Process (PPAP) Failure Modes and Effects Analysis (FMEA) Statistical Process Control (SPC) Measurement System Analysis (MSA) Design of Experiments (DOE) or process validation methodologies.
American Society for Quality certifications such as Certified Quality Engineer (CQE) Certified Supplier Quality Professional (CSQP) or Six Sigma Green Belt or Black Belt certification.
For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.
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.
U.S. Work Authorization & Sponsorship
At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @ email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic do not respond click links or open attachments.
If you have any questions concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic please contact us immediately at .
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
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
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
