TekWissen LLC
Location
Warren, MI | United States
Job description
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Client is a leading provider of transfusion and transplantation diagnostic products worldwide. We strive to create a world where anyone, anywhere in need of blood or transplantation gets the right blood or transplant that is safe, accessible and affordable.
Position: Quality Manager
Location: Warren, NJ, 07059
Duration: 1+ Months
Job Type: Contract
Work Type: Onsite
Description:
Maintain quality system compliance with ISO 13485, QSR, IVDR, CMDR, MDSAP, and any other global regulations. Remain up to date on current and upcoming regulations and guidance's.
Participate in the development, planning and implementation of reagents, assays, software and hardware life cycle management for client automated instrumentation and qualification of new/revised test methods, equipment and product/process validation initiatives related to manufacturing.
Supports the design and development of new products and participates in process design and development core team activities. Responsible for preparing the Quality and Risk Management Plans associated with both existing and new products.
Overall responsibility for Quality Operations approval of Design Transfer activities from R&D to Manufacturing, inclusive of production and manufacturing process qualifications.
Support manufacturing via review and approval of Root Cause Investigations.
Provide on-going feedback to all functional groups to improve product quality and compliance throughout the design and manufacturing of products.
Oversight and coordination of the Change Control and CAPA (deviation, NCMR, OOS, CAPA) programs.
Provide guidance to area owners on completion of action items.
Interact with management as necessary to accomplish project goals and objectives.
Assist the Management Representative in escorting and providing information to Regulatory officials during external audits.
Manage the new hire and ongoing training programs for quality-related subjects.
Manage the QA review and approval of incoming material, labeling, line opening/closing, in-process and finished device history records, including BASIS release and ERP transactions
Support the QA review and approval of product, process, facility and equipment validation protocols and reports following current quality management system requirements
Manage the QA storage locations for all quarantine and retains in accordance with associated procedures
Manage the trending of metrics related to the Quality Management System and share with site management.
Manage personnel attendance and perform employee appraisals and competency evaluations as required.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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