Quality Engineer II

Medtronic•Humacao, PR

7d•Onsite

About The Position

The Quality Engineer II – New Product Introduction (NPI) is responsible for ensuring product and process quality throughout development, validation, process transfer, and production readiness for machining and selected secondary operations such as anodizing and final pack. This role provides quality oversight to cross-functional teams to ensure manufacturing processes, equipment, components, and documentation meet design intent, regulatory requirements, and Medtronic Quality Management System expectations. The role is expected to drive compliance with GMP, FDA, and ISO requirements through disciplined documentation, traceability, investigation support, and audit readiness. This position also strengthens product and process robustness by analyzing data, identifying quality risks, supporting nonconformance and CAPA activities, and partnering closely with Manufacturing, Engineering, Supply Chain, and Quality functions to enable successful product launch and sustained operational performance.

Requirements

Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
Engineering degree required
Strong knowledge of Process Validation (IQ/OQ/PQ) and risk-based validation approaches
Experience with Machine Complete / equipment qualification and production readiness
Proficiency in risk management tools (FMEA, hazard analysis, risk assessments)
Knowledge of statistical methods (SPC, capability analysis, DOE preferred)
Root cause investigation tools ( 5 Why, Fishbone, DMAIC )

Nice To Haves

Bachelor’s degree required in Engineering, preferably Mechanical, Industrial, Chemical.
Minimum of 3 years of relevant engineering or quality experience required, or a Master’s Degree in Engineering with at least one co-op or internship experience, preferably within the medical device or other regulated manufacturing industry.
Demonstrated technical writing capability for protocols, reports, investigations, and quality documentation.
Working knowledge of Quality Management Systems, including document control, nonconformance management, CAPA, change control, and risk management.
Familiarity with regulated manufacturing requirements and standards such as FDA Quality System Regulation, ISO 13485, and GMP expectations.
Knowledge of equipment, process, and product validation concepts, including IQ, OQ, PQ, and risk-based validation approaches.
Experience using data analysis and statistical methods such as SPC, capability analysis, or DOE to support investigations and continuous improvement.
Lean Six Sigma Green Belt certification or training preferred.
Hands-on experience with statistical software such as Minitab or equivalent tools for trending, capability studies, and root cause analysis.
Experience with automation, data extraction, or basic programming tools such as VBA, Python, or similar platforms to support reporting and process analysis.
Experience applying root cause analysis and risk assessment tools such as 5 Whys, Fishbone, or FMEA in manufacturing or quality environments.
Working knowledge of manufacturing systems or MES tools to support process controls, data integrity, and investigation activities.
Strong critical thinking, problem-solving, communication, and cross-functional collaboration skills in a fast-paced manufacturing environment.
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.
Provides quality engineering support for new product introduction activities, including process development, validation, qualification, and production readiness.
Partners with Manufacturing, Process Development, and Engineering teams to establish and maintain effective quality controls for machining and secondary manufacturing processes.
Develops and implements methods for inspection, testing, validation, and process evaluation to ensure equipment and products consistently meet defined requirements.
Uses statistical analysis and quality engineering tools to assess process capability, support component and process qualification, and investigate products or materials that do not meet specifications.
Ensures investigations, corrective actions, validations, and supporting documentation are compliant, technically sound, and inspection-ready.
May lead or support activities related to process quality, incoming materials, product evaluation, validation, change management, and continuous improvement as part of product lifecycle support.