Quality Engineer II

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

Bring your talents to an industry leader in medical technology and healthcare solutions. 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.

Join us for a career in IT that changes lives.

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

• Provides Quality System support and guidance to maintain compliance with all FDA and international regulatory requirements.
• Support the Articulating Technologies QMS; partner pragmatically with the organization to ensure QMS processes related to General QMS and Pilot production are established, implemented, and maintained in a compliant manner.
• Support the EU OU Surgical entities from a Quality Oversight perspective, including proactive support (e.g., helping set up QMS processes, audits, and certifications) and reactive support related to production quality issue resolution, PHO, and FCA support.
• Coordinate and/or prepare 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.
• Own and drive nonconforming product investigations, root cause analysis, and resulting corrective and preventive actions (CAPA); perform trend analyses and report compliance observations to identify areas for improvement; investigate and resolve compliance problems, questions, or complaints from other units, customers, and regulatory agencies.
• Maintain mastery of applicable Quality, FDA Medical Device directives/regulations, and ISO requirements by updating policies and procedures and acting as a liaison with appropriate policy experts.
• Apply excellent writing, editing, and computer skills; travel within the EU and internationally approximately 10–25%.

Required Knowledge and Experience:

• Relevant bachelor’s degree with a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.
• Demonstrated knowledge of quality system elements and regulatory requirements (e.g., FDA, GMP, QSR, ISO 13485, and MDSAP) for finished medical devices, with the ability to implement and communicate requirements in a regulated healthcare industry; knowledge of medical device manufacturing processes/requirements.
• Effective use of data analysis tools; strong analytical, research, and problem-solving skills with keen attention to detail, the ability to understand the “big picture,” and a desire to follow an audit trail to identify risks, nonconformances, and true root cause.
• Outstanding written, oral communication, and presentation skills.
• Sound judgment; ability to make decisions, work independently, and manage and execute multiple critical projects simultaneously; capable of managing multiple priorities and escalating issues.

2 or more years of relevant experience in a medical device manufacturing setting (or equivalent such as packaging and labeling and/or distribution) and experience supporting and/or participating in regulatory inspections and audits are considered advantages for this role.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.