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Principal Quality Engineer
Northridge - Medtronic
Job Title: Principal Quality Engineer
Location: Northridge, California
Careers That Change Lives
- Plan, coordinate, and execute Medical Device Risk Management activities to ensure the safety and reliability of Medtronic MiniMed products throughout out the lifecycle of the product (from concept to end of life).
- Support the development of a state of the art Medtronic Diabetes Device Risk Management program and system, including both pre-market and post-market activities.
- Serve as subject matter expert (SME) for risk management and quality system processes.
- Coach and provide guidance to associate Engineers and cross functional teams regarding risk management processes.
The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes so people with diabetes can enjoy greater freedom and better health.
Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.
A Day in the Life
- Support cross functional teams in conducting risk management activities.
- Facilitate development of thorough, accurate and practical risk estimations, risk controls and benefit/risk analyses by working closely with Medical experts and other cross-functional teams with limited oversight from management.
- Analyze production and field data for Medtronic products to determine if changes to the risk profile have occurred, and to initiate and coordinate risk control activities as required.
- Lead and coordinate Issue Impact Assessments (IIA), including providing key input to facilitate timely Field Corrective Action decisions.
- Lead and coordinate Field Corrective Actions, including liaising with regulatory bodies and collaborating with cross functional teams across multiple Medtronic departments and business units.
- Present and communicate clear and concise information to senior management, large cross functional teams, external auditors and regulatory inspectors.
- Drive continuous improvement of related quality system processes and tools, including but not limited to updating procedures and deploying training.
- Perform other duties as assigned.
- Travel up to 10% as required.
To be considered for this role, the following minimum requirements must evident on your resume.
- Bachelor's degree in an Engineering or Science-related field with at least 7 years' experience or Master's degree in an Engineering or Science-related field with at least 5 years' experience or PhD in an Engineering or Science-related field with at least 3 years' experience
- 3 years' experience in the medical device industry
- Experience with ISO Quality Management System (ISO 13485), US FDA Quality System Regulation (21 CFR 820), and relevant international standards such as IEC 60601-1
- Experience with risk management process (ISO 14971), including risk assessment tools & methodologies
Nice to Have:
- More than 5 years' experience in roles of increasing responsibility in quality assurance, quality engineering, regulatory affairs, or clinical affairs in a regulated environment.
- Strong project management skills, including coordinating large cross functional teams and presenting to senior management.
- Experience conducting data analysis with Excel, Minitab, or other similar programs.
- Ability to write technical reports, business correspondence, and technical procedures.
- Good understanding of clinical aspects as related to Class III medical devices.
- Good understanding of post market vigilance and complaint handling practices.
- Good understanding of field corrective actions, including recalls, field actions, field safety corrective actions, and safety notices.
- Self-starter and accountable, with sharp focus on quality and customer experience.
- Effective verbal and written communication and interpersonal skills.
- Ability to perform work with minimal supervision.
- Ability to provide solutions to difficult technical issues associated with specific projects.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
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 Day in the Life 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.
Travel up to 10%
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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http :// www.uscis.gov/e-verify/employees
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