Quality Systems Specialist

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 Quality Systems Specialist supporting the Electronic Implantables & China Manufacturing platform, you will have responsibility for managing and supporting Quality System and Product related activities to ensure compliance with Supplier Controls established in the Quality Management System (QMS).

This position is in Danvers, MA.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

A Day in the Life

In general, the following responsibilities apply for the Quality Systems Specialist role. This includes, but is not limited to the following:

· Position supports day to day activities required to ensure QMS compliance.

· Oversees and manages the timeliness and operational aspects of managing the CAPA and NCMR processes in their electronic software system.

· Provides weekly reports to the site for CAPA and NCMR timeliness.

· Responsible for data analysis of CAPA and NCMR sources and root causes.

· Leads weekly CAPA board meetings and maintains meeting minutes.

· Supports internal and external audit and inspections, including preparation and resolution of audit and inspection findings.

· Responsible for developing, communicating, and documenting process improvements and decisions.

· Functioning effectively as part of cross functional and cross organizational teams, developing strong partnering relationships with Manufacturing Engineering, Quality Engineering, and Operations.

· 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.

· Travel requirement: Less than 10%

Qualifications –

Must Have - Minimum Requirements

TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

· Bachelor’s Degree in Quality or Engineering, Science, or technical discipline

· Minimum of 2 years of work experience OR Advanced degree in Quality or Engineering, Science or technical discipline with 0 years years of work experience.

Nice to Have

· Experience working in quality systems where these regulations and guidelines are followed: 21 CFR Part 820, 21 CFR Part 11, MDSAP, EU MDR, ISO13485, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC

· Working experience in CAPA / NCMR.

· Highly developed skill set in project leadership practices, including ability to balance risk and benefit, effectively influence diverse teams, and ownership of responsibility for outcomes

· Strong interpersonal, organization and presentation skills; Excellent downward, lateral, and upward communication skills

· Strong competencies in judgment and problem solving (especially root cause analysis)

· Skilled at facilitation, consensus building and conflict resolution with peers

· Demonstrated ability to handle multiple tasks accurately and efficiently

· Good balance of high level strategic and detailed tactical thought processes.

· Knowledge and experience with Lean/Six Sigma methodologies and/or Design for Reliability and Manufacturability (DRM); Greenbelt certification preferred

· Proficient in word processing, spreadsheets, and project management tools

· Experience with Trackwise and Agile MAP quality system databases

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)