Principal Quality Systems Specialist at Medtronic in San Diego, California

Job Description:

Principal Quality Systems Specialist

20000IJB

San Diego, CA or Northridge, CA

Careers That Change Lives

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health, and extend life for millions of people worldwide.

In this exciting role as a Principal Quality Systems Specialist the position will report to the Quality Assurance Manager at our San Diego, California facility and will have responsibilities associated to our Diabetes Insulin Delivery Device. This position will include a variety of duties such as the creation and development of systems and queries to produce monthly reporting for complaint trending and monitoring as well as information associated to complaint investigations with the applicable engineers in R&D or manufacturing - including training or education if related.
DIABETES
Transforming diabetes care together, for greater freedom and better health.

Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Bachelors degree with 7+ years of experience in Quality and/or regulated industry OR Advanced degree with 5+ years of experience in Quality and/or regulated industry.

Nice to Have (Preferred Qualifications)

• Medical Device Equipment manufacturing experience


• Knowledge of FDA CFR 820 Requirements and ISO 13485

About Medtronic

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 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. (ADA-United States of America)

Up to 25% travel.

Additional Information

• Posting Date: Nov 12, 2020
• Travel: Yes, < 25 % of the Time