Sr Quality Engineer

Medtronic•Humacao, PR

20h

About The Position

The Senior Quality Engineer provides quality engineering leadership for machining and selected secondary operations, including anodizing and final pack. This role ensures product and process quality by partnering with cross-functional teams to confirm that manufacturing processes, equipment, components, and documentation meet regulatory requirements, and Medtronic Quality Management System expectations. The role drives compliance with GMP, FDA, and ISO requirements through disciplined documentation, traceability, investigation support, and audit readiness. The Senior Quality Engineer also strengthens product and process robustness by analyzing data, identifying quality risks, supporting nonconformance and CAPA activities, and collaborating with Manufacturing, Engineering, Supply Chain, and Quality partners to enable successful product launch and sustained product lifecycle quality activities, including process quality, incoming materials, product evaluation, validation, change management, and continuous improvement.

Requirements

Requires a Bachelor's 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.
Engineering Degree required
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.
Experience working in a regulated manufacturing environment, preferably medical devices, pharmaceutical, or other highly controlled industry.
Working knowledge of quality system expectations, including documentation, nonconformance handling, corrective and preventive actions, change control, and audit readiness.
Ability to support manufacturing process quality activities, investigations, validation deliverables, risk assessments, and product/process performance monitoring.

Nice To Haves

Preferred bachelor’s or master’s degree in Mechanical, Industrial, Electrical engineering.
Experience in medical device or other FDA/ISO-regulated manufacturing environment, 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 equipment, process, product, and software validation concepts, including URS, SRS, IQ, OQ, PQ, risk-based validation, and implementation readiness.
Experience supporting machining, anodizing, final pack, inspection, test methods, component qualification, or other manufacturing process controls.
Experience applying root cause analysis and risk assessment tools such as 5 Whys, Fishbone, FMEA, fault tree analysis, or similar structured methods.
Experience using SPC, capability analysis, DOE, trending, sampling rationale, or statistical methods to support investigations, process monitoring, and continuous improvement.
Hands-on experience with Minitab, JMP, Excel advanced functions, Power BI, PowerPoint, SAP, JDE, Factory Works, or similar systems used for data analysis, reporting, traceability, and manufacturing execution.
Lean Six Sigma Green Belt, Black Belt, or equivalent training/certification preferred.
Demonstrated ability to write clear, technically sound, and audit-ready protocols, reports, investigations, justifications, and quality documentation.
Strong critical thinking, communication, prioritization, and cross-functional collaboration skills in a fast-paced manufacturing environment.
Experience with data extraction, automation, dashboards, or basic programming tools such as VBA, Python, Copilot, ChatGPT, Gemini, or similar applications to improve reporting and process analysis.

Responsibilities

Partner with Manufacturing, Process Development, and Engineering teams to define, implement, and sustain effective quality controls for machining and secondary manufacturing processes.
Develop and implement inspection, testing, validation, and process evaluation methods to ensure equipment, components, and products consistently meet established requirements.
Apply statistical analysis and quality engineering tools to evaluate process capability, support component and process qualification, and investigate products, materials, or processes that do not meet specifications.
Ensure investigations, corrective actions, validations, and supporting documentation are compliant, technically justified, risk-based, and inspection-ready.
Lead or support product lifecycle quality activities, including process quality, incoming materials, product evaluation, validation, change management, and continuous improvement.
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.