Medtronic
Sr Quality Engineer
Juncos, Puerto Rico, United States of America · Senior
Stay score
odds of building a lasting career here
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Green-card intent detected
Green-card follow-through: 59%
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- 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.
- Please keep the following in mind: Apply only through official Medtronic channels.
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.
- Support quality system compliance with Good Manufacturing Practices (GMP), U.S. Food and Drug Administration (FDA) regulations, ISO 13485 requirements, and internal procedures.
- Ability to collaborate effectively with cross-functional teams including engineering, manufacturing, and quality organizations.
Requirements
- 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
- 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.
- 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.
Nice to have
- 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. § 214.2(h)(4)(iii)(A) is required.
- Physical Job Requirements
- 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.
Compensation
- Benefits & Compensation
Company info
- U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact.
- 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. Recruitment Fraud Alert We are aware of phishing scams targeting job seekers.
Visa & Work Authorization
- U.S. Work Authorization & Sponsorship
This listing is sourced directly from Medtronic's careers page and normalized into a canonical job model.