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Quality Assurance Specialist

Company: Think Surgical
Location: Fremont
Posted on: January 12, 2021

Job Description:

Company 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 worldwideJob DescriptionThe QA Specialist is an experienced person within the medical device industry with knowledge performing their function within the FDA Quality System Regulations (QSRs), ISO 13485:2003, and MOD. The QA Specialist has the ability to perform various quality assurance duties under minimal supervision and to work in accordance with THINK Surgical, Inc. Standard Operating Procedures (SOPs).Perform Device History Record review and release functionsReview certificates of compliance or test reportsReview receiving inspection documentationReport non-conformances and discrepanciesPerform, in-process and final inspections in accordance with written procedures, statistical sampling plans, engineering drawing and specifications.Perform a wide range of complex or precision inspection procedures to determine quality levels of parts or products at various stages in production, including final acceptance,Maintain and operate inspection and test equipment (e.g., optical measurement system, micrometer, caliper, pin gages, microscope, tensile tester, etc,)Perform first article inspection and informs appropriate personnel of results, Assist in the analysis and reporting of SPC data,Provide technical quality support to the Manufacturing/Operations engineer(s)Ensure the traceability of components and products are maintained at every inspection points.Document, file, and maintain all inspection documents.Create and modify documents contained in the Quality System, such as manufacturing procedures, forms, standard operating procedures, and initiate DCOs, as appropriate.Participate in internal audits and audits by regulatory bodies (e.g. FDA, Notified Body).Responsible for implementing assigned corrective actions and NCMRs. Executes other quality projects and non-routine duties as assigned by the QA manager.Qualifications High school degree required. Minimum five (5) years QA/QC experience within the medical device industry.Proficient with engineering drawings and specifications, inspection sampling plans, and dimensional/visual inspection equipment.Ability to read English and comprehend verbal and written instructions, including technical and safety information.Good verbal communication and writing skills.Effective problem-solving skills and detailed oriented.Ability to work in a team minded approach to achieve individual and company success.Proficient with personal computer software including word processing and spreadsheets.Knowledge of good manufacturing practices (GMP) and applicable Quality System Standards.Attendance and Punctuality are essential function of the position.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.SummaryType: Full-timeFunction: Quality Assurance

Keywords: Think Surgical, Fremont , Quality Assurance Specialist, Other , Fremont, California

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