Safeguard Medical, a global alliance of leading healthcare organisations, with category-leading devices and ground-breaking SIMBODIES simulations are looking for a strong team player, with a can-do and flexible attitude to join its Quality Department based at Blizzard.
Blizzard Protection Systems Ltd, part of the Safeguard Medical Group, is based on the edge of Snowdonia in North Wales and offers a range of high-quality Passive Warming Systems using our unique material Reflexcell™. Offering the best insulation property of any comparable product for the treatment and prevention of hypothermia.
This is a fantastic opportunity, to become part of the team at our production facility in Bethesda.

JOB SUMMARY

Reporting to the QA Manager, the QA Assistant is responsible for ensuring that the organization conforms to quality standards and regulatory requirements. S/he is responsible for assisting with the execution of the Quality Team duties. S/he will be responsible for examining products and materials for defects or deviations from specifications of the Quality Management System (QMS). This is a highly visible position that will require attention to detail and the ability to communicate effectively with all levels of Team members across the company.
Oversees and monitors the inspection and testing of materials, parts, and products to ensure adherence to established quality standards. Recommends changes in specifications of materials, parts, and products based on inspection results. May formulate and revise quality control policies and procedures. Working team member that may validate or coordinate the work of others on a support team. Suggests improvements to process, is a knowledge resource for other team members.
Job holder to promote and adhere to the company values of quality and compliance with current legislation.

SKILLS AND QUALIFICATIONS

• Minimum of 2 years experience of working in a quality assurance role.
• Experience of working in manufacturing in a medical device or regulated industry
• Training of EN ISO 14971
• ISO 13485training
• Internal Auditor training
• Internal auditor:
  o personal behavior (ethical, open minded, diplomatic, observant, perceptive, versatile, open to improvement, collaborative)
  o 3x internal audits supervised by a Lead Auditor.

• Perform line inspection prior to production runs; review/approve line clearance documentation
• Perform inspection and release of product labeling prior to production, perform label reconciliation and final record review at completion of production runs.
• Perform in-process inspection of product during production runs; final inspection of product at completion of production runs.
• Supporting the design and maintenance of the Quality System.
• Participate in Internal and External quality audits as directed by the QA Manager
• Assist in the development of procedures for the test and inspection of articles
• Perform incoming inspection and release of medical devices, device materials, components and subassemblies
• Contributing to the provision of education and training on relevant compliance activities particularly relating to QMS requirements for all -SMT employees
• Maintaining distributor records
• Providing Sales Team support for Tenders, new Distributor accounts and product documentation request
• Drafting and contributing to the creation of production process work instructions and assembly records
• Assisting with assembled product release
• Preparation, attendance and contribution to monthly quality management meetings
• Complying with all safety policies, practices and procedures
• Supporting the monitoring and measuring activities, including NCRs, CAPAs
• Key participant within the QA/RA team in the execution of their duties.
• Keeping up to date with current medical device guidelines, legislation and publications, assessing the impact of changes to the organisation
• Risk management Team Member
• Assist with the review of documentation
• Conducting Internal Audits
• Other duties as assigne