- Maintain quality system compliance with ISO 13485, QSR, IVDR, CMDR, MDSAP, and any other applicable global regulations. Remaining up-to-date on current and upcoming regulations and guidances.
- Support manufacturing via review and approval of Root Cause Investigations, deviations and nonconformances.
- 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 site management as necessary to accomplish project goals and objectives.
- Participate in the development, planning and implementation of reagents, assays, software and hardware life cycle management for automated instrumentation and qualification of new/revised test methods, equipment and product/process validation initiatives related to manufacturing.
- Overall responsibility for Quality Operations approval of Design Transfer activities from R&D to Manufacturing, inclusive of production and manufacturing process qualifications.
- Assist the Quality Management Representative in escorting and providing information to Regulatory officials during external audits. Support supplier and internal audits, as needed.
- Manage the new hire and ongoing training programs for quality-related subjects. Manage personnel attendance and perform employee appraisals and competency evaluations as required.
- 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 managementQualifications:
Minimum Knowledge & Experience required for the position: - Bachelors degree in a science related field (biology, chemistry, biomedical, etc)
- A minimum of five (5) years experience in medical device, IVD (in-vitro diagnostics), and/or pharmaceutical experience required
- Two(2) or more years experience in a quality management role, managing a team of 3 or more team members.
- Extensive knowledge of Quality System Regulations (QSR). Working knowledge of 21 CFR 820, ISO 13485, EU IVDR, CMDR
- Proficiency in MS Office
- Experience with an eQMS is preferred (i.e. TrackWise or MasterControl)
- Strong consultative and interpersonal skills
- Ability to prioritize and multi-task
- Strong attention to detail and ability to summarize and communicate at all levels of the organization
- Team player (displays enthusiasm, confidence & commitment)
- Exceptional communication ability (verbal & written)
- Strong presentation skills. Facilitation and Leadership skills
- Ability to take initiatives and work independently
- Strong problem solving and analytical skills APPLY NOW FOR IMMEDIATE CONSIDERATION
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Quality Operations Manager - Warren, United States - MyKelly
Description
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a direct hire opportunity to work as a Quality Operations Manager located in Warren, NJ.
Shift: Monday-Friday, first shift, onsite
Pay: $90k max (salary dependent on experience)
The Manager of Quality Operations leads a team of quality specialists and ensures that product is produced that meets design specifications, quality system requirements, and regulatory requirements. This is a hands-on manager role that is directly involved with day-to-day operations required to produce medical device products.
