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Senior Quality Engineer

Company: Truvian
Location: San Diego
Posted on: June 20, 2019

Job Description:

Job Description Truvian Sciences is seeking a highly motivated and passionate Senior Quality Eningeer to join the Quality/Regulatory group. Cover letter and resume required for application. Apply through Linked in or send your cover letter and resume to Responsibilities: Ensure compliance with all relevant FDA 21 CFR 820, Design Control, Risk Management ISO 14971, ISO 13485 regulatory requirements, and internal Quality Standards for product development and manufacturing - Creates and applies policies and procedures for identifying, analyzing and controlling risk throughout the product life cycle Conducts evaluations, tests, verifications, validations and makes decisions to maintain Quality objectives Designs and installs quality process sampling systems, procedures and statistical techniques Conducts training and supervises other engineers and inspection personnel in execution of Quality tasks Promotes success through development of methods and arguments for achieving company objectives while adhering to Quality/Regulatory requirements Actively represent Quality Assurance function on product/process development teams Hands on participant in early stages of product development including but not limited to product engineering, competitive product testing, prototype development and prototype testing Participate in development, review and approval of product requirements, product specifications, test protocols and reports Review new and modified product design for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirement Interact with component suppliers on product development projects and quality issues Establish, implement, and validate inspection plans, equipment and procedures Develops quality inspection criteria for incoming inspection and final inspection Lead the product development team through the risk analysis process including product hazard analysis, DFMEA, PFME, risk benefit analysis, and risk management planning and reporting supporting compliance with ISO14971 Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques Conduct oversight of the design control process for new product development teams Lead and participate on internal and external audit teams Design and conduct testing for products and process validations Conduct capability studies for production processes Preparation of data analyses and recommendation for actions Applies statistical sample size calculations to work for quality determination on projects of intermediate scope/complexity Conduct product investigations, root cause analysis, and implementation of corrections and preventative actions Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of IVD product Ability to work independently, with minimal supervision Consistently demonstrates "above the line" behaviors in the day to day execution of job duties Excellent communication skills Utilizes a constructively assertive approach that reaches out, speaks up, and drives continuous improvement Take the initiative on any QA related issues with regards to compliance and quality Qualifications: Bachelor of Science degree in engineering, physical or life sciences Moree than seven years' experience in quality engineering in the IVD or Medical Device industry Advanced familiarity with IVD and biotech product development and manufacturing processes Experience in Quality System Requirements Experience with EQMS and ERP Organizational, planning and detail follow-up skills required Understanding of design of experiments Excellent written and verbal communication skills Strong analytical skills and effective problem-solving ability Risk analysis technique, FMEA, Fault tree, and Hazard Analysis Ability to work in a multi-functional team environment Ability to handle and resolve conflicts and work under schedule/milestone pressures Demonstrated ability to lead fast track investigations through analysis to outcomes for decision Demonstrated ability to be flexible and resourceful. Good communication and diplomacy skills required

Keywords: Truvian, San Diego , Senior Quality Engineer, Engineering , San Diego, California

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