Quality & Regulatory Manager – Syracuse Location

RESPONSIBILITIES:

Regulatory

1.1. Manage Company’s External and Internal Audit programs – SGS and FDA QSR.

1.2. Manage Company’s products compliance to FDA UDI regulations.

1.3. Ensure that Company’s products meet national and international regulatory requirements for manufacturing, distribution and sales.

1.4. Ensure that all personnel are made aware of all current and forthcoming standards; understand the implications; report on the potential impact.

1.5. To carry out risk management on new and existing products, as required.

1.6. Maintain Temporary Import Bond program for products that are export only.

1.7. Ensure that FDA Establishment Registration Listings are maintained, renewed and up to date for Company (Wokingham and Guernsey) and Company UAB (Lithuania).

1.8. Function as Official Correspondent and US agent for the FDA for Company, Company Ltd (Wokingham and Guernsey) and Company UAB (Lithuania).

1.9. Function as Senior Official for Device Licensing to Health Canada. Ensure that Medical Device Licenses with Health Canada are maintained, renewed and up to date.

1.10. Responsible for responding and reporting incidents to all approved markets:(FDA and Health Canada).

1.11. Provide customers with product registration information and technical data.

1.12. Act as a resource for all Customer service personnel in handling customer queries.

1.13. Prepare and submit documentation for market clearance with FDA (510(K)).

Management Representative

1.1. To report on the performance of the Regulatory updates at semi-annual Management Review Meetings.

Customer Service

1.1. Provide customers with product registration information and technical data.

1.2. Act as a resource for all Customer service personnel in handling customer queries.

Production

1.1. Assist Logistics in production planning so that accurate data is maintained on stock, routing, bills of material, delivery dates and purchase requirements.

Miscellaneous

1.2. Setting department aims and communicating accordingly.

1.3. Maintain competency in the Quality functions to be able to provide backup within the Quality Department.

RESPONSIBILITIES:

Quality

1.1. Ensure the Quality Management System is fully implemented, documented, maintained and in compliance with ISO 9001, ISO 13485, FDA-QSR and CMDR standards and regulations.

1.2. Step-by-step action required to develop and implement Company’s Standard Operating Procedures (SOPs).

1.3. Assessment of changes to any controlled company activity and documentation that affects the form, fit or function of a product or document to ensure an Engineering Change Order (ECO) is issued, documented and kept up to date.

1.4. Initial handling, evaluation, investigation, completion and final review of complaints in a uniform and timely manner.

1.5. Monthly monitor compliance of control measures implemented to ensure that the contracted cleaning and pest control services do not result in potential product contamination.

1.6. Responsible to perform the particle counts in the controlled environment area on a monthly basis.

1.7. Ensure that permanent and temporary employees are adequately trained as per their position required Standard Operating Procedures (SOPs) and document individual records through Company’s training matrix.

1.8. Monitor compliance and conduct inspections on a quarterly basis of receiving products solely for initial distribution at Company’s external warehouse as per ANSI/ASQCZ1.4-1993 General II Normal inspection sample.

1.9. Monitor compliance of receiving procedure for production related materials.

1.10. Review and approve product labels for Finished Good Production and labels created by a vendor for use on U.S. distributed finished product packages.

1.11. Review and approve literature, catalogues and other printed or electronic marketing material as needed.

1.12. Review and approve Master Product Formulas (MPF’s) for products provided by key suppliers.

1.13. Creation, update and maintenance of Device Master Records (DMRs)/Device History Records (DHRs), perform the necessary inspection steps and document the compliance on the inspection checklist. Responsible for final lot release.

1.14. Monitor the operating procedures for controlled environment areas, monthly review, approval and maintenance of a controlled environment area cleaning schedule/checklist.

1.15. Establish calibration intervals, identify equipment requiring calibration and arrange recalibration of all measurement equipment within specified time limits. Maintenance of a calibration program is also required.

1.16. Responsible for all production equipment maintenance, qualification, and validation checklists/schedules into the production process.

1.17. Vendor evaluation: Annual revision of sub-contractors' and suppliers' performances. Advise on the suitability of new suppliers (products, components, services).

1.18. Effective identification and evaluation for reporting adverse medical device events to FDA. Ensure timely submission of complete reports.

1.19. Responsible for Identification and Traceability of products during all stages of receipt, production, and distribution including monthly inspections at Company’s external warehouse.

1.20. Responsible for the review and final disposition of nonconforming product via a Material Review Board.

1.21. Determine if a product complaint and/or MDR/MPR warrants a product recall. Product Recall.

1.22. Identify adverse conditions and implement corrective and preventive actions including verification activities to ensure effectiveness of the system.

1.23. Creation and maintenance of Custom Circuit Matrix to process requests and quotes for any product not listed in current Company’s catalogues.

1.24. Report on the performance of the Quality system at semi-annual Management Review Meetings.

1.25. To manage Company’s External and Internal Audit programs – SGS, ISO, and QSR.

Management Representative

1.1. To report on the performance of the Quality system at semi-annual Management Review Meetings.

1.2. Ensuring quality system is effectively established and maintained.

Customer Service

1.1. Assist in the processing custom clinical sample and new custom product requests.

1.2. Assist in the processing Return Goods Authorization (RGA) requests in accordance with company policies and guidelines.

Production

1.1. Assist Logistics in production planning so that accurate data is maintained on stock, routing, bills of material, delivery dates and purchase requirements.

1.2. To oversee the efficiency and quality of production processes.

Miscellaneous

1.3. Setting department aims and communicating accordingly.

1.4. Maintain competency in the Regulatory functions to be able to provide backup within the Regulatory Department.

Job Type
Full-Time Regular
Location
Syracuse/East Syracuse NY