Quality Engineer II (Validation, Manufacturing Operations)
MedtronicAbout the role
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 Quality Engineer II supporting manufacturing operations, you’ll work at the front lines of product quality and compliance. You will collaborate closely with production, engineering, and quality teams to support daily operations, drive process improvements, and ensure that all products meet Medtronic’s high standards and regulatory requirements. Your focus will be on ensuring consistent quality of manufactured products and resolving production challenges efficiently and effectively.
Key Responsibilities
Serve as the quality point of contact for manufacturing lines, providing guidance on quality issues and helping ensure day-to-day compliance.
Monitor and analyze process and product performance data to identify trends, drive root cause analysis, and support continuous improvement.
Lead or support nonconformance investigations, risk assessments, and corrective/preventive actions (CAPA) related to manufacturing processes.
Support validation of manufacturing processes, equipment, and cleaning procedures (IQ/OQ/PQ).
Review and approve work instructions, inspection plans, process changes, and deviations.
Participate in internal and external audits, ensuring readiness and effective response to findings.
Champion the use of Lean Six Sigma, statistical tools, and problem-solving methodologies.
Collaborate cross-functionally with operations, engineering, and supply chain to ensure product quality and operational efficiency.
Must Have: Minimum Qualifications
Bachelor’s Degree AND minimum of 2 years related experience OR
Advanced Degree with 0 years of experience
Nice to Have: Preferred Qualifications
Knowledge of FDA QSR (21 CFR 820), ISO 13485, and GMP principles.
Experience with manufacturing process validations and quality assurance techniques.
Strong analytical and communication skills, with a collaborative and solutions-oriented mindset.
ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt certification.
Experience in a high-volume, highly regulated manufacturing environment.
Working knowledge of PFMEA, control plans, and statistical process control (SPC).
Familiarity with quality software systems (e.g., TrackWise, Agile, SAP, Minitab).
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
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.
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