A Day in the LifeThe Quality function partners across engineering, manufacturing, and operations to ensure products and processes meet regulatory, quality, and customer requirements throughout the product lifecycle. This team drives product and process quality through quality system oversight, continuous improvement, statistical analysis, and cross-functional collaboration.
This position is based in Juncos, Puerto Rico and follows an onsite work model.
The Senior Quality Engineer is responsible for driving product and process quality initiatives within a regulated manufacturing environment. This role partners closely with engineering and manufacturing teams to implement quality standards, lead complex investigations, analyze quality data, and support continuous improvement efforts that enhance compliance, reliability, and operational performance.
Primary Responsibilities- Lead complex Corrective and Preventive Action (CAPA), Nonconforming Material Report (NCMR), and root cause investigations to identify systemic issues and implement sustainable corrective actions.
- Partner with engineering and manufacturing teams to establish, maintain, and improve product and process quality standards.
- Develop, implement, and maintain quality protocols, procedures, and inspection strategies for manufacturing processes and products.
- Design and execute inspection, testing, and evaluation methods to verify product quality and process effectiveness.
- Apply statistical analysis techniques, including Statistical Process Control (SPC), trend analysis, and Minitab tools, to identify risks, monitor performance, and drive data-based decisions.
- Assess product and process nonconformances, determine root causes, and ensure corrective actions meet reliability, compliance, and quality requirements.
- Support quality system compliance with Good Manufacturing Practices (GMP), U.S. Food and Drug Administration (FDA) regulations, ISO 13485 requirements, and internal procedures.
- Mentor and coach junior Quality Engineers while promoting a culture of quality and continuous improvement across the site.
Required Qualifications- Bachelor's Degree in Engineering and a minimum of 4 years of relevant experience; OR Master's Degree and a minimum of 2 years of relevant experience; OR PhD.
- Experience supporting quality engineering activities within a regulated manufacturing environment.
- Experience conducting investigations, assessing nonconformances, and implementing corrective actions.
- Experience using statistical methods and data analysis to evaluate product or process performance.
- Ability to collaborate effectively with cross-functional teams including engineering, manufacturing, and quality organizations.
Preferred Qualifications- Advanced knowledge of Good Manufacturing Practices (GMP), U.S. Food and Drug Administration (FDA) regulations, ISO 13485, and Quality System Regulations.
- Experience leading complex CAPA, NCMR, and root cause investigations.
- Expertise with Minitab, Statistical Process Control (SPC), trend analysis, and process capability assessments.
- Lean Six Sigma Green Belt or Black Belt certification.
- Experience with manufacturing process controls, inspection optimization, digital quality systems, and quality data analytics tools.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. a7 214.2(h)(4)(iii)(A) is required.
Physical Job RequirementsThe 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.
U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official [redacted].com email addresses.
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Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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).
Medtronic benefits and compensation plans
