Senior Manufacturing Quality Engineer

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

As a Senior Manufacturing Quality Engineer , you will play a key role in ensuring that products are manufactured in compliance with internal quality standards, regulatory requirements, and Medtronic’s commitment to patient safety and product excellence. This position partners closely with Manufacturing, Operations, R&D, and Supply Chain to drive quality improvements and support continuous improvement initiatives on the production floor.

This role is responsible for ensuring compliance, quality, and operational excellence throughout the development and manufacturing of Class III medical devices.

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

• Maintain and continuously improve the Quality Management System in compliance with ISO 13485, EU MDR, and FDA QSR (21 CFR 820)
• Support Operations activities, including manufacturing, validation, MRB, CAPA.
• Oversee CAPA, nonconformances, deviations, complaints, risk management, change controls, document control, and training processes.
• Actively participate in and support internal and regulatory audits, including preparation, execution, and follow-up.
• Collaborate cross-functionally with R&D, Regulatory Affairs, Operations, and Supply Quality teams.
• Support production, engineering, validation activities including training, reviewing and approving documentation, work instructions, SOPs , supporting risk assessments, to ensure compliance with regulatory and quality system requirements.
• Lead and support investigations of nonconformances, deviations, and CAPAs, including root cause analysis and implementation of corrective and preventive actions.

Required Knowledge and Experience:

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related field.
• 7+ years of QA production experience (Senior Quality) in medical device – MUST
• In- depth knowledge of FDA 21 CFR Part 820, ISO 13485/14971, and EU MDR.
• Strong analytical and problem-solving skills.
• Ability to work effectively in a cross-functional, fast-paced manufacturing environment.
• Strong communication skills in English, both written and verbal.
• Hands-on experience with ECO’s, nonconformance management, CAPA, and root cause analysis tools.
• Experience conducting investigations, identifying root causes, leading corrective actions and applying risk management and statistical tools.
• Knowledge of Lean, Six Sigma, or continuous improvement methodologies- advantage

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
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.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

About Medtronic

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