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Quality Assurance Inspector

Genmark Diagnostics, Inc

Quality Assurance Inspector

Carlsbad, CA
Full Time
Paid
  • Responsibilities

    Quality Assurance Inspector - 2nd Shift - TEMP Quality Assurance Carlsbad, California Description At GenMark, were changing the diagnostics landscape, combining out-of-the-box thinkers and game-changing technology to revolutionize patient care. Our work atmosphere is dynamic, fast-paced, and patient-focused. We encourage teamwork, while reinforcing the importance of individuality, and encouraging an entrepreneurial spirit. GenMark is a leading provider of automated, multiplex molecular diagnostic testing systems. Utilizing GenMark's proprietary eSensor detection technology, GenMark's eSensor XT-8 system and ePlex sample-to-answer systems are designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark is not just a job its a way of life. We also provide opportunities to volunteer in the community, participate in sports leagues, and enjoy company social events. Position Summary This position performs verifications to ensure that incoming materials, parts, and components used in the manufacture of GenMark products meets all mechanical, electrical and cosmetic specifications as identified in the quality inspection plan using various inspection tools. The candidate interfaces with various departments including quality assurance, quality control, product technical support, and production personnel to: (1) ensure sufficient inventory for production needs and (2) resolve any associated quality issues that arise from product inspection. Essential Duties and Responsibilities * Responsible for day-to-day receiving inspection of all incoming materials following quality control compliance procedures.

    • Conduct incoming inspection (manual and automated), final system inspection, and other quality inspections for particular areas or products as needed. * Accurately document the results of the verifications. * Document (NCR) inconsistencies observed during quality inspections for product or material verification. * Conduct first article audits, including creation of audits finding reports and working with responsible parties to determine proper resolution. * Maintain all controlled document files and verification records in a timely and accurate manner. * Participate in the construction and/or revision of SOPs for the inspection function. * Assist in the writing and updating inspection procedures and checklists. * Work closely with the Quality Engineering and purchasing to improve the product/test capability and receiving inspection process, while striving to improve quality and reduce cost through communication and problem solving, tracking nonconformance causes and participating in work area meetings. * Work closely with Materials personnel to ensure that accurate inventory controls are being followed; responsible for completion of cycle counting materials in receiving inspection area as well as the accuracy of inventory transactions. * Must be able to lift up to 25 pounds on an occasional basis. * Must be willing and able to work weekday, weekend and mandatory overtime hours as required to meet the production demands of the team. * Able to work independently, also balances team and individual responsibilities, exhibits objectivity and openness to others views, gives and welcomes feedback, contributes to building a positive team spirit, able to build group commitments to goals and objectives, supports team efforts. * Detail oriented, is accurate and delivers quality work, Looks for ways to improve and promote quality, demonstrates accuracy and thoroughness, applies feedback to improve performance, monitors own work to ensure quality and Sense of urgency. Position Requirements Education and Experience: * Minimum HS diploma and two plus (2+) years Quality Control experience in Receiving Inspection is preferred. Skills Technical * Working knowledge of & ability to use precision measurement equipment such as optical comparators, micrometers, calipers, height and thread gages, power supplies, impedance bridges, voltmeters, multimeters, etc. * Experience performing inspections on mechanical, electrical, and optical components and assemblies. * Experience in reading and interpreting mechanical drawings and specifications. * Experience with First Article Inspections, inspections of returned materials (RMAs), and repaired materials returned from vendors. * Proven ability to prioritize responsibilities in a high pressure, dynamic, multi-tasking environment. * Experience working in an FDA regulated environment is preferable. Skills General * Must be a hands-on, self-directed, detail oriented and conscientious individual * Complete work in a timely, accurate and thorough manner * Must be able to think and work both tactically and strategically to provide financial and operational needs to GenMarks business * Effective analytical problem solving, judgment and decision making skills are required * Strong time management and organizational skills in a dynamic, constantly changing environment * Ability to read, write and analyze complex documents * Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals * Ability to work effectively, exhibit a professional manner and establish constructive working relationships Work Environment * The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment. * While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. * The employee may sometimes be required to lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus. GenMark Dx does not accept agency submittals. Please do not forward resumes to our Executive team, Management team, or any current GenMark employee for review. GenMark Dx is not responsible for any fees related to unsolicited resumes. GenMark is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of any kind: GenMark is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at GenMark are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. GenMark will not tolerate discrimination or harassment based on any of these characteristics. GenMark encourages applicants of all ages. GenMark participates in E-Verify. GenMark is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.
  • Industry
    Manufacturing