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.

A Day in the Life

The Senior Quality Systems Specialist develops and maintains quality assurance programs to ensure that the performance and quality of Medtronic products conform to established standards and agency  guidelines.  Primary job responsibilities include CAPA management, audit program management and Quality Management System improvements.

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

• Provides oversight for the 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 complying with policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Product Servicing QA activities support – Technical Service Bulletins, Equipment Out of Tolerance Reports, Service procedure maintenance.
• Supports audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups through all stages of the audits.
• Prepares reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders.
• Supports the quality assurance programs and policies maintenance and modification regularly.
• Drive Quality Management System (QMS) & product continuous improvement through CAPA management.  Elevate issues to management as appropriate.
• Coach new CAPA owners through processes and best practice.
• Develop and maintain Compliance policies supporting the Risk Management program.
• Support process improvement projects and assessment of quality plans.
• Support management during external/internal inspections and participate in the management of external/internal inspections.
• Maintain working knowledge of domestic and international medical device regulations and guidance documents and their impact on Medtronic’s operations.

Must Have: Minimum Requirements

• Bachelor’s Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 3+ years of work experience in Engineering and/or Quality.
• Expertise in CAPA compliance & investigation techniques.
• Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP.
• Training in Risk Management, ISO 14971, hazard analysis, and Design FMEA.
• Must work well in cross-functional teams and be a self-starter.
• Excellent written and verbal communication skills.
• Excellent organizational skills.
• Computer literacy must include proficiency with MS Office and experience with networks and applications.

Nice to Have

• Master’s degree in Engineering, Program Management, or Compliance
• Lead Auditor Certification to ISO 13485:2016
• ASQ CQE, CQA, CSQE and/or CRE certification.
• Familiar with statistical software tools (Minitab, Stat Graphics, Statistica),
• Familiar with IEC 60601 and product specific industry standards.
• Excellent interpersonal and influence skills including efficient collaboration, effective negotiation, and creative problem solving.
• Strong technical experience in complex technology development programs including ability to understand technical information, discuss/decide on a wide array of engineering disciplines and technical/logistical issues.

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 Of