Sr Quality Engineer

Medtronic•Humacao, PR

8d•Onsite

About The Position

The Sr. Quality Engineer supports quality assurance activities within a regulated manufacturing environment, ensuring products and processes meet applicable quality, regulatory, and business requirements. This role is responsible for supporting investigations, nonconformance management, CAPA, change control, validation deliverables, risk assessments, process monitoring, and audit readiness. The position partners cross-functionally with manufacturing, engineering, supplier quality, and operations teams to resolve quality issues, drive continuous improvement, and maintain compliance with FDA, ISO, GMP, and internal quality system expectations. The ideal candidate brings strong technical problem-solving skills, quality systems knowledge, manufacturing process experience, and the ability to produce clear, technically sound, audit-ready documentation.

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’s degree in engineering required.
Minimum of 4 years of relevant engineering, quality, or manufacturing experience required; or a master’s degree in engineering with a minimum of 2 years of relevant experience OR PhD with 0 years relevant experience.

Nice To Haves

Bachelor’s or master’s degree in Mechanical, Industrial, or Electrical Engineering preferred.
Experience in medical device or other FDA/ISO-regulated manufacturing environments, including GMP expectations and inspection readiness.
Practical knowledge of ISO 13485, FDA Quality System Regulation expectations, nonconformance management, CAPA, document control, change control, and risk management.
Knowledge of validation concepts for equipment, processes, products, and software, including URS, SRS, IQ, OQ, PQ, risk-based validation, and implementation readiness.
Experience supporting NPI, product transfers, supplier qualification, supplier performance monitoring, component qualification, and supplier quality improvement initiatives.
Manufacturing process knowledge in areas such as machining, anodizing, final packaging, inspection, test methods, component qualification, or other process controls.
Experience applying structured problem-solving and risk assessment tools, such as 5 Whys, Fishbone, FMEA, fault tree analysis, or similar methodologies.
Experience using statistical and data analysis methods, including SPC, capability analysis, DOE, trending, sampling rationale, and process monitoring.
Hands-on experience with tools such as Minitab, JMP, advanced Excel, Power BI, PowerPoint, SAP, JDE, Factory Works, or similar systems.
Lean Six Sigma Green Belt, Black Belt, or equivalent continuous improvement training/certification preferred.
Experience using automation, dashboards, data extraction, or basic programming tools such as VBA, Python, Copilot, ChatGPT, Gemini, or similar applications to improve reporting and process analysis.
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.