Sr Quality Engineer
About The Position
The 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.
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; 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.
Nice To Haves
- 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.
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.
Benefits
- Competitive Salary
- Flexible Benefits Package
- Medtronic Incentive Plan (MIP)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
