Sr Quality Engineer
Medtronic · Juncos
QualityFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Medtronic seeks a Senior Quality Engineer to provide quality leadership and oversight of manufacturing operations in Puerto Rico, ensuring products and processes meet regulatory and business requirements. The role involves risk management, process validation, and cross-functional collaboration to drive quality improvements and compliance.
What they're looking for
- Bachelor's degree in Engineering with 4+ years relevant experience
- Advanced knowledge of GMP, FDA, ISO 13485, and Quality System Regulations
- Experience leading complex CAPA, NCMR, and root cause investigations
- Expertise in statistical analysis tools including Minitab, SPC, and trend analysis
- Lean Six Sigma Green Belt or Black Belt certification
- Knowledge of manufacturing process controls and process capability analysis
- Unrestricted U.S. work authorization required
What you'll be doing
- Develop and maintain quality standards and protocols for material processing and product manufacturing
- Design inspection and testing mechanisms; conduct quality assurance tests and statistical analysis
- Collaborate with engineering and manufacturing teams to ensure quality standards compliance
- Lead corrective measures implementation and ensure documentation meets regulatory requirements
- Provide oversight of equipment and process validation activities; lead site-wide quality initiatives
Privacy & handoff
This role links to Medtronic's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.