P-393737 Quality Systems Specialist

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

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

• JOB DESCRIPTION:

• Lead and schedule internal audits according to the QMS calendar.
• Coordinate audit logistics, back-end preparation, document retrieval, and follow-up on findings.
• Conduct internal audits and support external audits (ISO 13485, FDA 21 CFR Part 820, MDSAP).
• Collaborate with functional departments to plan validations and risk assessment activities.
• Report and track QMS KPIs and drive continuous improvement initiatives.
• Support layered audits, Gemba walks, and process walkthroughs.
• Assist in CAPA effectiveness checks and regulatory readiness support.
• Serve as a cross-functional compliance checkpoint for management review or inspection readiness.

• JOB REQUIREMENTS:

• Education: University degree
• Experience: At least 3 years in a similar role; experience in the medical device or other regulated industries is a plus.
• Skills:
  • Proficient in Microsoft Office (Word, Excel, Outlook, etc.).
  • Proficient in English skills.
  • Strong organizational, communication, and interpersonal skills.
  • Understanding of document control practices and regulatory compliance.
  • Detail-oriented, responsible, and able to handle confidential information with integrity.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

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. 

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.
 

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here