Medtronic is an Equal Opportunity/Affirmative Action Employer
Plan, coordinate, and execute activities to ensure the quality and reliability of Medtronic MiniMed products. Assure the timely, accurate and independent evaluation of product performance and compliance to safety and regulatory requirements prior to manufacturing and market release.
Develop, execute and/or monitor manufacturing quality plan to and quality engineering tasks in manufacturing process validations and controls to ensure compliance with established requirements and regulatory expectations.
Provide support for released products, evaluate product field performance and reliability, recommend corrective actions, and actively participate in continuous improvements.
Represent Quality in product development teams/projects. Develop & execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory) to ensure provisions for quality are addressed & resolved prior to release.
Coordinate with the development of essential design control deliverables including, but not limited to product performance analysis on similar products, essential requirements checklist, product specifications, risk analysis, failure mode and effects analysis, fault tree analysis, design verification / validation, design reviews, phase reviews, and product release authorization for distribution of product.
Work closely with business functions and project teams to develop appropriate verifications (DVT), validations (software, process), and qualifications (subcontractors, system and subsystems), for both new design and changes to released product.
Review design inputs (specifications) and design outputs (reports, drawings, etc.) to assure that appropriate design requirements are specified and to evaluate/confirm quality requirements prior to successful design transfer.
Review & approve product verification and validation plans and reports.
Participate in CCB to review and approve engineering change requests.
Participate in Material Review Board (MRB) to review & disposition nonconformities and to coordinate & supplier corrective actions.
Work with Manufacturing to direct, coordinate & monitor the production processes that are in compliance to FDA QSR, ISO 13485 and other applicable regulatory requirements (JPAL, Canada, etc.); and to ensure that safe and effective products are produced.
Provide validation support by applying manufacturing quality toolset including but not limited to: FTA, FMEA, DFEMEA, PFMEA, IQ, OQ, PQ, analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.
Participate in complaint investigations and failure analysis of returned products; document findings and provide reports and analysis to CAPA bodies (QIT & CIT). Compile & institute quality metrics to trend, recommend and implement corrective action and appropriate follow-up when necessary.
Perform other duties as assigned.
Bachelor of Science Degree in Engineering or Science-related field
3 years related experience in Quality Assurance and/or Quality Engineering and/or R&D or Operations in a regulated environment (medical device).
2 years experience in bio-medical or other regulated industry.
Familiar with ISO quality system (ISO13485), USFDA Quality System Regulation, and relevant international standards.
Self-Starter and accountable, with sharp focus on quality and customer experience.
Familiar with in pFMEA, dFMEA, risk analysis and management.
Working knowledge of problem solving and statistical methods as applied to process and product quality.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write technical reports, business correspondence, technical procedures as well as administrative procedures.
Ability to present proposals, data, and issues to Medtronic MiniMed personnel at all levels.
Ability to independently determine and develop approach to a wide range of issues and problems. Solutions must be thorough, practical, and consistent with organization objectives.
Ability to perform work with minimal direction and supervision.
Ability to represent the department in frequent inter-organizational and outside vendor contacts.
Ability to provide solutions to difficult technical issues associated with specific projects.
Ability to independently determine and develop technical solutions to a wide range of difficult problems.
MS Degree in Engineering (Electrical, Biomedical, Mechanical or equivalent).
More than 5 years related experience in Quality Assurance and/or Quality Engineering in a regulated environment.
Certified Lean or Six Sigma Black Belt.
Project Management experience.
Experience working with remote suppliers and facilities, both domestic and international.
ASQ certification in Quality or Reliability
An ability to interact with senior external personnel on significant technical matters often requiring coordination between organizations.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
Job entails the frequent manipulation of large pieces of equipment.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell.
Must be able to work within a Class 1000-Class 10000 clean room environment.
Must be able to examine subassemblies and work-in progress using a microscope operating at up to 100 x magnification.
Must be able to work in environments such as chemical lab with the appropriate protective equipment or in a machine shop where noise can be on the moderate side.
Employee must occasionally lift and/or move up to 50 pounds.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
On Call/After hours Support - May be required to support process and design validation efforts during weekends and 2nd shift.
Medtronic - 15 months ago
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...