We anticipate the application window for this opening will close on - 1 Aug 2025

 

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 Engineer plays a critical role in ensuring the compliance, robustness, and effectiveness of the Quality Management System (QMS) in alignment with global regulatory requirements and internal policies. This individual will serve as a subject matter expert (SME) across multiple quality subsystems - such as CAPA, Internal Audits, Document Control, and Training - supporting cross-functional teams and driving continuous improvement.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. 

Key Responsibilities:

• Lead the maintenance, execution, and continuous improvement of core Quality System elements (e.g., CAPA, NCR, Change Control, Document Management, Audit, Training).

• Ensure QMS compliance with applicable regulations and standards (e.g., FDA 21 CFR 820, ISO 13485, EU MDR, MDSAP, CMDR).

• Serve as Quality SME during internal/external audits (e.g., FDA, Notified Bodies, Corporate), supporting audit readiness, walkthroughs, and remediation efforts.

• Author, review, and revise quality system procedures, work instructions, and policies to ensure clarity, regulatory alignment, and operational efficiency.

• Drive and support cross-functional CAPA investigations, root cause analysis (e.g., 5-Why, Fishbone, Fault Tree), effectiveness checks, and timely closure of actions.

• Monitor and report on Quality System health metrics, identifying trends and opportunities for system-wide improvements during monthly reviews and quarterly Management Review.

• Partner with functional owners to ensure timely training, gap closure, and system compliance across the organization.

• Support QMS harmonization and integration efforts through evolving business needs and/or regulatory changes.

• Mentor and coach junior quality team members and functional stakeholders on QMS best practices.

Minimum Qualifications:

• Bachelor's degree plus 4+ years of experience in Quality or Engineering (or 2+ years with an advanced degree).

Nice to Have:

• Bachelor’s degree in Engineering, Life Sciences, or related field.

• Experience in the medical device, pharmaceutical, or life sciences industry.

• Strong working knowledge of FDA QSR, ISO 13485, ISO 14971, EU MDR, and MDSAP regulations.

• Proven experience leading CAPA investigations, internal audits, or regulatory inspection preparation.

• Excellent attention to detail, organization, and communication skills (verbal and written).

• Ability to lead cross-functional teams and influence without authority.

• Proficiency with electronic QMS platforms (e.g., Agile, TrackWise, or similar).

• Certification in quality (e.g., ASQ CQE, CQA, or Lead Auditor).

• Experience working in a multi-site, global organization.

• Familiarity with risk management files, design controls, or software validation is a plus.

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 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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package