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Quality Engineer

Company: THINK Surgical, Inc.
Location: Fremont
Posted on: May 3, 2021

Job Description:

47201 Lakeview Blvd, Fremont, CA 94538, USAFull-timeCompany DescriptionTHINK Surgical, Inc. develops, manufactures and markets the only active robotic surgical systems for orthopedic surgery. The systems include two components: a 3D workstation for preoperative planning, and a computer assisted tool utilized for cavity and surface preparation for hip and knee replacement surgeries. The systems have been used in thousands of joint replacements worldwide.Job DescriptionThe Quality Engineer is responsible for the quality assurance of product design and supplier controls / performance. He / she must understand and be able to implement the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485. He/she initiates and facilitates improvements to the quality system while providing technical support to R&D, Manufacturing, and Supply Chain. This position serves as a Quality representative on new product development and provides technical support and leadership of quality deliverables. Also responsible to support R&D and Operations during all product development phases and support creation of design controls as well as process qualification/validation activities, statistically sound sampling plans and process control plans including inspection/test method development and product investigations resulting from field complaints.Ensure that vendors / suppliers deliver quality products, materials, and services in accordance with specifications, purchase orders, and quality agreements. Monitor parts from purchasing through the manufacturing cycle. Communicates and resolves supplier-related problems as they occur. Assists in evaluating suppliers' performance and provides feedback.Support activities associated with supplier quality within a medical device environment. Collaborates with Regulatory, Supply Chain, Quality, Manufacturing, Engineering, and Customer Support for compliance to all specifications. Develops, applies, and reviews procedures in accordance with 21 CFR 820 and ISO 13485. Collaborates with new & existing product development teams to ensure quality standards are met. Support and/or lead supplier quality activities such as supplier qualification, supplier audits, inspection plans, root cause analysis, CAPA investigation, and supplier performance monitoring.Facilitate the incorporation of quality systems/regulatory requirements in accordance with FDA QSR (21 CFR: Part 820), ISO13485, European MDD / MDR, and all other applicable regulationsPromote and audit corrective actions and continuous improvement efforts for quality management systems.Promote and audit corrective actions and continuous improvement efforts for quality management systems.Provide active support for internal, third party and customer audits. This requirement includes the post audit requirements for reviewing, dispositioning, mitigating and incorporating any observations, non-conformances, opportunities for improvement and potential gaps/preventive actions.Participate in the risk management process ensuring, when applicable, that hazards are adequately mitigated in product and process quality plansAnalyze, develop and maintain key metrics for trends indicating the effectiveness and suitability of the QMS and identify areas for improvement.Provide guidance to other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to Think Surgical productsSupport new product introduction projects through development and execution of process validation and verification test plans, protocols, and reportPlan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devicesCreate Quality PlansPerform DHF/DHR review for product release.Assist the Quality Department on an as-needed basis.Other duties or MDD/MDR projects as required to meet company's objectivesQualificationsRequired QualificationsBachelor's degree (or equivalent experience) with 3-5 years of related experienceCertified Quality Engineer a plusAble to travel up to 10 % of the timeExperience with the creation of Procedures, Protocols, Test Reports, and Work InstructionsParticipate in Risk Analysis (Design/Process) meetings and action requirementsAbility to manage priorities and workflow in a rapidly changing environmentExperience working in a cross-functional team environmentExperience with robotics/software a plusExperience with Medical Device Manufacturing a plusExcellent organizational, problem-solving, and analytical skillsGood interpersonal skillsParticipate with internal quality auditsPreferred QualificationsExperience with medical instrumentation and disposables, in a regulatory environmentWorking knowledge of basic quality systems regulations such as QSR and ISO.Proficient technical writing skills and use of documentation programs (Example Office Windows, Excel, Access, Power Point, etc.).Working knowledge of fundamental quality and statistical toolsPossess excellent interpersonal and communication skills with the ability to develop trust, respect and confidence with internal and external customers.Knowledge of good manufacturing practices (GMP) and applicable Quality System Standards.Attendance and Punctuality are essential function of the position.Drives resultsOptimizes work processesDecision QualityPhysical Demands & Work EnvironmentMust be able to remain in a stationary position and operate office equipment for a prolonged period of time.Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.Occasionally work around moving mechanical parts.Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.Must be able to travel as business necessitates (up to 10 % Travel%).Additional InformationTHINK offers a fast-paced, dynamic environment with the advancement potential of an entrepreneurial company. We provide a competitive compensation package that includes comprehensive benefits, a company-matched 401k plan, and more. We strive to build the strongest and brightest teams in the industry. If you would like to work on tomorrow's leading orthopedic solutions today, we would love to hear from you.THINK is an equal opportunity employer that hires a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.47201 Lakeview Blvd, Fremont, CA 94538, USASDL2017

Keywords: THINK Surgical, Inc., Fremont , Quality Engineer, Other , Fremont, California

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