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Quality Assurance Manager

Company: Ultimate Staffing
Location: Oceanside
Posted on: April 2, 2021

Job Description:

\n\n ESSENTIAL JOB FUNCTIONS QUALIFICATIONS \n\n Provide BMS support, including the management of the Quality Assurance department. This includes the management of personnel and their activities, overseeing all stages of inspection: receiving, in-process, finished goods, returned goods. Oversee raw material and supplier quality, Document Control, corrective and preventive action, and design and development support in order to maintain and enhance compliance with ISO 13485 requirements. Key Auditor Trainer - provide in-house training and refresher training for the Internal Auditing group. Facilitate the corrective and preventive action program and assist the responsible parties as to the activities required to close the CAPA actions. Will also conduct verification audits to ensure that previous CAPA taken is closed and effective. Facilitate Management Review following completion of the internal audit and initiation of corrective and preventive action activities, develop the agenda, help correlated the data for presentation to Top Management, and initiate any corrective and preventive actions resulting from Management Review. \n\n \n \n\n \n\n PREFERRED EXPERIENCE \n\n 3-5 years of direct medical device and /or manufacturing experience. Experience with receiving inspection plan development. Experience with sterile disposable products a plus Knowledgeable of FDA/QSR Quality System, ISO 13485 requirements and Medical Device Directives \n\n EDUCATION \n\n \n\n------------------High School diploma or some College or equivalent combined work experience and/or school experience.\n\n \n\n \n \n\n \n\n OTHER REQUIREMENTS \n\n Physical --- Will be required to move raw materials and equipment with assistance Inspection tools --- Must have working knowledge of the use of basic Calipers, scales/rulers, Micrometers. Must be able to read product specifications/drawings \n\n Proficiency office software programs (MS Word, Excel, etc.), Visio a plus.\n\n \n\n \n\n \n\n 1. Responsible for the evaluation and quality reporting of customer complaints, returns and trending of these returns.\n\n \n\n 2. Responsible for gathering all inspection data that supports the monthly and quarterly generation of quality measures and reports.\n\n \n\n 3. Supports the Supply Chain Management processes to assure that the QS is compliant to all regulatory agency requirements.\n\n \n\n 4. Takes a QA support role on all New Product Development teams.\n\n \n\n 5. Oversees the Calibration program.\n\n \n\n 6. Participate in Internal, FDA and ISO audits.\n\n \n\n 7. Assigned as required to support Customer driven projects \n\n As the person responsible for regulatory compliance (PRRC Representative), the QA Manager shall at least be responsible for ensuring that: \n\n (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;\n\n \n\n (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;\n\n \n\n (c) the post-market surveillance obligations are complied with in accordance with MDR (EU) 2017/745, Article 10(10);\n\n \n\n (d) the reporting obligations referred to in MDR (EU) 2017/745, Articles 87 to 91 are fulfilled;\n\n \n\n (e) in the case of investigational devices, the statement referred to in MDR (EU) 2017/745, Section 4.1 of Chapter II of Annex XV is issued\n\n

Keywords: Ultimate Staffing, Oceanside , Quality Assurance Manager, Executive , Oceanside, California

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