Sr Quality Engineer

Medtronic•Juncos, PR

About The Position

The Senior Quality Engineer provides quality leadership and oversight for manufacturing daily activities, ensuring products and manufacturing processes meet regulatory, quality, and business requirements. This role partners with cross-functional teams to drive risk management, product disposition, problem solving, change control, and improvement projects while supporting risk burndown initiatives at the site. This role also provides oversight to equipment and process validation activities.

Requirements

Requires a Baccalaureate degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
Bachelor Degree in Engineering
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 (Minitab, SPC, trend analysis).
Lean Six Sigma Green Belt or Black Belt certification.
Knowledge of manufacturing process controls, inspection optimization, and process capability.
Knowledge of digital quality systems and data analytics tools.
Capability to lead site-wide quality culture initiatives.
Ability to coach and develop junior Quality Engineers.
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.

Responsibilities

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.