Regulatory Affairs & Quality Assurance Manager
CoWorx Staffing Services is seeking RA/QA Manager serves as the lead for Quality Assurance and Regulatory Affairs at our client site in Tyngsboro, MA.
The RA/QA Manager is responsible for the design, management, day-to-day operation, and periodic evaluation of the quality management function for products, processes, and services. The RA/QA Manager is the outward-facing representative for regulatory affairs and its internal guide and source of information on government regulations, responsible for all the activities through which the company maintains its regulatory compliance.
Requirements:
Master’s or bachelor’s from an accredited college or university or five or more years of experience in the field
- Experience in product development and/or manufacturing and production, metrology, material characterization,
medical devices, biology, polymers and/or biomedical engineering preferred, but not required.
- Experience in QMS auditing in a regulated environment.
- Experience in writing standard operating procedures, quality assurance protocols, work instructions, and forms.
- Knowledge of international, national, state, regional and local laws, rules, regulations, and conventions
applicable to company products and services, including but not limited to ISO 13485, and FDA QSMR, and the
separation of Quality Assurance and Production.
- Experience with implementation and management of Production Part Approval Process (PPAP), preferred but
not required.
- ASQ certification (or relevant training/experience) is preferred but not required.
Position duties:
- Ensure compliance with FDA and other applicable domestic and international regulations and requirements, and ISO compliance regulations, for the design and development of medical devices, including FDA’s Quality System Management Regulation (21 CFR Part 820) and related FDA regulations, ISO 13485, ISO 9001, ISO 14971, ASTM, European Medical Device Regulation, and others.
- Ensure regulatory compliance of product realization process for the company’s product lines.
- Lead the development, implementation, and oversight of QMS and related quality procedures, work instructions, and forms to conform with all applicable standards and coincide with operational and process-related changes to daily workflow. Report regularly to leadership about quality issues, where appropriate.
- Lead and implement all quality-based efforts related to any current or future manufacturing, packaging, sterilization, and Production Part Approval Process (PPAP) requirements of customers. Report regularly to leadership about quality issues, where appropriate.
- Perform monitoring and management of ongoing product conformity requirements and lead efforts to ensure timely evaluation of nonconforming products. Collaborate with the Management Team and lead the effort to ensure that there are no repeat non-conformances from regulatory or client audits.
- Lead the review and approval of site corrective action plans for product and process QMS audits.
- Provide general regulatory leadership and strategy for the organization by sharing information, identifying issues to be addressed, collaborating with company leadership on production and other decisions impacted by government regulations, and reporting regularly to leadership about regulatory issues.
- Responsible for regulatory compliance of risk management, validation, and conformity evaluation activities within the organization.
- Lead the implementation of an eQMS system, upgrading from an effective paper-based system, and manage the ongoing utilization of the eQMS system after implementation.
- Facilitate external Quality System audits (ISO registration, Client Supplier Quality, Vendor Audits, etc.) and guide the organization during FDA Inspections (QSIT format).
- Conduct Management Reviews to monitor the suitability and effectiveness of QMS implementation.
- Assist the company’s Management Representative of the quality system, and official correspondences to FDA, responsible for the annual registrations and device listings.
- Directly supervise specific staff members. Support other company managers in supervising their staff in regulatory affairs and quality management.
Lead the company’s understanding and awareness of US, EU, and other international regulatory requirements to ensure compliance. Disseminate up-to-date information and provide guidance and continuing education.
- Participate in committee work of global standards organizations, such as ASTM and ISO, as opportunities arise.
Please email your resume of interest for review to: 0144@coworxstaffing.com or call for more information on how to apply! 978-496-1585
CoWorx Staffing Services, LLC
235 Littleton Road, Unit 1
Westford, MA 01886
978-496-1585