Sr Quality Engineer

Senior Quality Engineer at Medtronic provides quality leadership and oversight for manufacturing operations in Puerto Rico, ensuring products and processes meet regulatory and business standards. The role partners with cross-functional teams on risk management, problem-solving, and improvement initiatives while overseeing equipment and process validation.

Responsibilities

• Develop and maintain quality standards and protocols for material processing and product manufacturing
• Collaborate with engineering and manufacturing teams to ensure quality standards are implemented and sustained
• Design inspection and testing mechanisms; conduct quality assurance tests and statistical analysis
• Lead corrective actions and ensure documentation compliance with regulatory requirements
• Oversee equipment and process validation activities across the site

Requirements

• Bachelor's degree in Engineering with minimum 4 years relevant quality 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 such as Minitab, SPC, and trend analysis
• Lean Six Sigma Green Belt or Black Belt certification
• Knowledge of manufacturing process controls and process capability
• Ability to lead quality culture initiatives and coach junior engineers