Sr Quality Engineer (Complaint Investigation Engineer)

Medtronic•Ponce, PR

2d•Onsite

About The Position

The Complaint Investigation Engineer role is critical to ensuring product quality, patient safety, and regulatory compliance. This position is responsible for leading and managing complaint investigations, performing thorough root cause analysis, and driving effective Corrective and Preventive Actions (CAPAs). The role also oversees risk management activities through the Internal Investigation Assessment (IIA) process to ensure that potential risks are properly evaluated and mitigated. Additionally, this position is responsible for analyzing and trending complaint data to identify systemic issues and opportunities for continuous improvement. Effective management of complaint investigations and CAPA activities is essential to maintain compliance with quality system regulations and internal procedures. Given the direct impact that complaint investigations have on product performance, regulatory reporting, and overall quality system effectiveness, this role plays a vital part in protecting patients, supporting business continuity, and ensuring that issues are promptly identified, investigated, and resolved.

Requirements

Engineering bachelor’s degree required 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.
Root Cause Analysis Investigation knowledge (CAPA, complaint, nonconformance etc.)
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.
Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for non-Principal level roles).

Nice To Haves

Validation IQ/MSA/OQ/PQ knowledge
Risk Management knowledge
Project Management knowledge
Microsoft Project, Minitab
Problem Solving
Pressure management
Teamwork
Time management
Attention to detail

Responsibilities

Lead and manage complaint investigations to ensure timely and thorough resolution.
Conduct risk management activities through the Internal Investigation Assessment (IIA) process.
Perform detailed root cause analysis to identify underlying issues.
Develop, implement, and monitor Corrective and Preventive Actions (CAPAs).
Analyze and trend complaint data to identify systemic issues and opportunities for improvement.
Ensure investigations, risk assessments, and CAPA activities are completed in compliance with applicable quality and regulatory requirements.
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.