Quality Engineer - Catheter Design MedVenture Technology Corporation
Identify and prepare quality requirements for product development projects based upon applicable regulatory requirements (i.e. FDA, JPAL, EU, etc.)
Develop and maintain the product development project Risk Management Plan (RMP) and aid in risk management documentation creation (FMEA).
Develop and maintain independent project Quality System Plans based upon internal and client SOP?s.
Support design verification activities (including biocompatibility, sterilization and package testing) per appropriate ISO, AAMI, and regulatory standards.
Develop, maintain, and execute component validations and external supplier qualifications along with test method development and validations.
Create/review/approve project related documentation
Initiate and complete nonconformance and corrective and preventative action (CAPA) plans/reports related to product development
Develop adequate sampling plans, inspection procedures, and test methods to maintain product performance and meet long term manufacturing goals (Yield/Scrap, LTPD, etc.).
Support other disciplines to complete design and process qualification documents and maintain Design History File (DHF) including performing internal audits of quality system and (DHF).
Support external audits from clients and regulatory agencies.
Create original quality related documentation and Device History Records (DHR) to support pilot builds and ongoing manufacturing in accordance with internal SOP?s and FDA GMP?s.
Provide support and expertise in DOE, reliability strategy, and analytical problem solving techniques.
Provide Quality reporting as needed and requested along with leadership and direction on project teams as it relates to the quality engineering functions.
Ensure sustaining quality engineer is trained on manufacturing testing and documentation prior to PPQ.
Develop training to build quality awareness.
Bachelor of Science degree in Engineering
Minimum 5 years? experience in quality engineering with catheter design and processing
Experienced in Medical Device Quality Systems (ISO 13485, ISO9000 and/or QSR) including the FDA.
Experience with Electrophysiology (EP) Systems
Proficient with reading engineering drawings, written specifications, production documentation, using calibrated inspection equipment such as gauges, calipers, smart scope, multimeters, manometers, pull test and other inspection equipment.
Leadership ability and organizational skills including time management
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work
Proficiency in the use of PC and programs, particularly Excel and Word to create procedures, work instructions, forms etc along with Minitab.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written).
Execute tasks in a timely manner without direct supervision.
Drive to learn new skills and innovative processes to solve complex problems based on data and risk assessment.
Able to prioritize tasks.
CQE, CQA (ratings)
Knowledge and direct experience with Controlled Environment room qualification and monitoring.
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