Site Quality Manager

Vernacare is dedicated to protecting safety and dignity while pioneering sustainable manufacturing in the areas of Infection Prevention, Clinical Waste Management, and Surgical Solutions. As pioneers of healthcare solutions, Vernacare has a history of developing products that enhance the lives of patients, residents, and healthcare professionals globally.

Role Description

This is a full-time role for a Site Quality Manager at Vernacare in Worksop. The Site Quality Manager will be the Quality Management representative (QMR), responsible for the Ownership, Development, Implementation, Maintenance and Continuous Improvement of the Vernacare Quality Management System in accordance with the requirements of ISO Standards and applicable regulations for the Vernacare site based in Worksop. The role holder will manage the QA activities on site and work closely with Global Quality, Global Regulatory Affairs, Product Management and Commercial teams to ensure effective implementation of the QMS and compliance with Regulatory requirements.

Responsibilities

• Plan, Co-ordinate, Conduct and Monitor activities related to the effective Implementation, Maintenance and Continuous Improvement of the various ISO and customer standards which make up the Quality Management System.
• Work closely with Top Level Management to develop and implement the Quality Plan, Quality Policy and Quality Objectives.
• Lead and manage the Quality Assurance team at the site, ensuring effective quality management practices are in place.
• Train and mentor team members on best practices in quality assurance.
• Develop, implement, and maintain quality assurance programs that comply with regulatory requirements and industry standards (e.g., ISO 13485, FDA regulations).
• Maintain a solid understanding of relevant Regulations and Quality System requirements that affect the business.
• Oversee New Product Development (NPD) initiatives, providing quality input into design control, validation, and risk management processes.
• Be the initial point of contact for Quality compliance matters.
• Prepare and present the Annual Management Review information.
• Perform internal quality audits, ensuring continuous improvement and compliance with quality standards.
• Establish and manage internal testing protocols, including validation and verification testing for new and existing products.
• Create and maintain comprehensive reports detailing the outcomes of internal tests, identifying trends, issues, and recommendations for improvement.
• Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure alignment on quality objectives and compliance.
• Co-ordinate and manage on-site Audits conducted by external parties.
• Act as the primary point of contact for quality-related inquiries and audits from regulatory bodies and external partners.
• Support Process Validation, Supplier Maintenance and Change Control activities.
• Report on the performance of the Quality System.
• Develop and maintain the effectiveness of local QMS in accordance with the company objectives and applicable requirements.
• Maintain, develop and/or revise QMS process documentation aligned with ISO 13485:2016 standard and other applicable site standards to incorporate appropriate regulatory requirements.
• Execute PMS activities, such as Product complaints, Product Field Actions and Commercial holds, in line with defined procedures and local regulations.
• Support Veterinary Medicinal product release to the market as per requirements of Statutory Instrument 2013 No 2033 (The Veterinary Medicines Regulation).

Qualifications, Skills and Experience

• Minimum 5 years of experience in Quality Assurance within the medical device industry and minimum 2 years managerial experience.
• Strong understanding of regulatory standards and guidelines relevant to medical devices (e.g., ISO 13485, FDA 21 CFR Part 820).
• Experience in New Product Development (NPD) and related quality processes.
• Proficient in data analysis and report generation, with strong attention to detail.
• Experience of working with Class 1 Medical Devices in accordance with MDD/MDR requirements.
• Experience of working with Notified Bodies and Competent Authorities.
• Experience maintaining a CE marked medical device under the Medical Device Directive (MDD) and working knowledge of the new European Medical Devices Regulation (MDR).
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively.
• Bachelor’s degree in engineering, life sciences, or a related field; advanced degree preferred.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Manufacturing

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