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DATE ADDED: Mon 20/01/2020

Quality Assurance Technician III

Tucson, AZ, US
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COMPANY: APEX SYSTEMS, INC

JOB TYPE: Permanent, FullTime

Job Description Job : 1037622 Quality Assurance Technician III Large, international medical device company needs to add a Quality Assurance Technician III. We are in growth mode and love to promote from within - so jump start your career with us while you contribute to bettering the lives of cancer patients. POSITION SUMMARY: The Quality Assurance Technician III is responsible for supporting various and a wide variety of activities within manufacturing and the QA team to ensure compliance with applicable regulatory and ISO requirements. The Quality Assurance Technician III will compile and review metrics and make recommendations for improvements to existing processes. This position will play a lead role in the MRB process. Such activities consist of but are not limited to; ensuring product meets established specifications and requirements, procedures are followed, records are accurate as well as appropriate, the Quality System is monitored and issues elevated when necessary. This position also requires decisions be made to determine appropriate actions are taken throughout processes as defined by our procedures. ESSENTIAL FUNCTIONS: -Create and monitor Non-Conforming Reports (NCRs) as required Responsible to control and monitor quarantined and non-conforming materials. -Understand the requirements of the Quality System such as; Good Documentation Practices, Quality Systems Procedures, Work Instructions, Quality Records, Verification activities, Audits, training, Design Transfers, Validations, Non-Conforming Product, CAPA, Production/Process Controls, ESD, Handling, and Document/Data Control. Compile, monitor and report Quality Assurance monthly metrics including identifying and/or preparing action plans for improvements. -Compile and maintain Quality Assurance daily metrics reporting any significant impact or opportunity to Quality Assurance and Quality Engineer managers -Provide feedback to team members, operations and the Quality Assurance manager as appropriate. -Responsible for routinely conducting departmental Quality and/or Safety Audits. -Review, evaluate and disposition Quality Data; Review and evaluate quality records and Device History Records (DHRs) to ensure accuracy, completeness, appropriate release and control of product(s). -Monitor Production Processes as required. Continuously promote "Right First Time." Lead/participate in investigations (relating to problems, potential problems, failures and/or complaint data) -Ensure compliance with quality system requirements as it applies to the output of the defined job specifications. - Coordinate manufacturing and development projects (including Design transfers) as required. -Participate in daily production meetings and continuous improvement initiatives. -Align with Quality Assurance team members that best balance with Quality, Operation, and Corporate objectives. Work with Engineers and subject matter experts to find root cause, participate in risk assessments, and create Change Orders. MINIMUM QUALIFICATIONS : Formal Training/Education: Associates degree in a related field. CQA, CQT or equally recognized formal certification in the field of Quality preferred. Experience: Minimum of 4 years of experience working in the area of Quality. Preferably 2 years' experience in an FDA and/or ISO regulated industry. Knowledge, Skills, and Abilities: -Ability to conduct detailed acceptance and verification activities. -Ability to perform ERP transactions using PC based applications (prefer). -Working knowledge of computer applications (i.e.; word, excel, Microsoft, Power Point & SAP). -Proficient in basic math and English; including verbal/written skills and be able to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. -Working knowledge of Reagent and/or Instrument manufacturing (use densities, tare weights, calculations to verify, interpret drawings, read gauges, knowledge of torques, etc.). -Ability to write reports, maintain data records, present information effectively and have strong communication skills with internal and/or external customers. Apply today to phoenix.apexlifesciences.com EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178. - provided by Dice
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