Quality Systems Specialist

BioCT Innovation Commons; North Haven (CT); On-site; USD 90,000 - 125,000; Full time

Job summary

Medtronic in North Haven, CT is seeking a Quality/Regulatory professional to drive investigations, root cause analyses, and corrective actions for finished medical devices. You will support the quality system, ensure regulatory compliance, and coordinate audits across the organization.

The role requires knowledge of FDA requirements, ISO 13485, QSR, MDSAP, and HIPAA, plus 4+ years of relevant experience. Expect travel about 25% and collaboration with multiple teams to advance patient safety and

Qualifications

• Bachelor’s Degree required.
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Knowledge of FDA, GMP, QSR and ISO 13485, and MDSAP for finished medical devices.

Responsibilities

• Own and drive investigations, root cause analysis and corrective and preventive actions.
• Provide quality system support and guidance to maintain compliance with all FDA and international regulatory requirements.
• Provide oversight for the development and maintenance of quality systems, programs, processes, and procedures to ensure ongoing compliance with policies and global regulatory requirements.
• Support EU Surgical Operating Unit entities from a Quality Oversight perspective including setup of QMS processes, audits and certifications; reactive support for production quality issue resolution, PHO and FCA.
• Partner with and influence internal and external stakeholders to drive needed change and the execution of compliance program.
• Communicate business-related issues or opportunities to next management level.
• Lead, coordination and/or preparation of internal and external audits in accordance with regulatory standards (FDA and equivalents outside the US as well as other authorities).
• Perform trend analyses and report compliance observations to identify areas for improvement.
• Investigate and resolve compliance problems, questions, or complaints from other units, customers, regulators, etc.
• Master knowledge of applicable Quality, FDA medical device directives/regulations, HIPAA and ISO requirements and update policies accordingly.
• Maintain excellent writing and editing skills and computer proficiency.
• Travel within US and internationally approximately 25%.

Skills

Writing skills

Computer skills

Education

Bachelor’s degree

Job description

We anticipate the application window for this opening will close on - 30 Oct 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare.

Join us for a career in IT that changes lives.

Careers that Change Lives

A Day in the Life

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

• Own and drive Investigations, Root Cause Analysis and resultant Corrective Actions and Preventive Actions
• Provides Quality System support and guidance to maintain compliance with all FDA and international regulatory requirements
• Provide oversight for the development and maintenance of quality systems, programs, processes, and procedures to ensure ongoing compliance with Medtronic policies and global regulatory requirements.
• Supporting the EU Surgical Operating Unit entities from a Quality Oversight perspective consisting of proactive support (example: helping, supporting entities with setting up QMS processes, audits & certifications) & reactive support related to production quality issue resolution, PHO and FCA support)
• Partnering with and influencing internal and external stakeholders to drive needed change and the execution of compliance program.
• Responsible for communicating business-related issues or opportunities to next management level
• Lead, coordination and/or preparation of internal and external audits in accordance with regulatory standards (including FDA and its equivalents outside the US as well as other government regulatory agencies / authorities) for the Operating Unit
• Perform trend analyses and report compliance observations to identify areas in need of improvement
• Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
• Mastering knowledge of applicable Quality, FDA (Food & Drug Administration) Medical Device Directives/ Regulation, HIPPA (Healthcare Information Patient Privacy Act) and ISO (International Organization for Standardization) requirements through the updating of policies and procedures and acting as a liaison with appropriate policy experts.
• Excellent writing and editing skills, and computer skills.
• Travel within US and International approximately 25%.

Basic Qualitications:

MUST HAVE: MINIMUM REQUIREMENTS:EDUCATION REQUIRED:

• • Bachelor’s Degree
• YEARS OF EXPERIENCE:
  • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
  • Demonstrated knowledge of all quality system elements and regulatory requirements (i.e. FDA, GMP, QSR and ISO 13485, and MDSAP) for finished medical devices with the ability to effectively implement and