Job Description
DD is looking to a Quality Manager, reporting to the Head of Quality due to growth and expansion within the business. We need a confident individual that is able to communicate technical requirements to a wide range of people and are comfortable questioning existing processes and procedures. You will be given autonomy and the freedom to make the role your own whilst providing industry-focused, comprehensive and consistent regulatory advice and support to managers and employees.
The Quality Manager will be responsible for ensuring that the systems and processes in place for current Good Distribution Practice, MHRA guidelines, Home Office controlled drugs license and ISO-9001: 2015 and ISO 13485 standards are adhered to and that the procedures and appropriate training for the team and wider DD Group sites are maintained.
Please note that a CV will be requested if you are shortlisted for an interview.
Main Duties and Responsibilities
- Ensure compliance with the general conditions of relevant Wholesale Distribution Authorisation, GDP Guidelines 2013/C 343/01, Human Medicines Regulations 2021 relevant MHRA Guidelines, legal requirements, and updates
- Ensure compliance with ISO 9001: 2015 and ISO 13485: 2016 standards.
- Ensure the QMS is implemented and maintained. The RP must approve, sign and date, all GDP SOPs/Documentation. Annual review of SOPs/Documentation will be carried out and documented.
- Ensure that the conditions of the WDA are met and that all medicinal products handled, are received, stored, transported, and delivered under strict GDP conditions.
- To manage the Quality team and liaise with relevant department heads to ensure full regulatory compliance at all times
- To ensure that the business has in place a QMS that is compliant with all relevant regulatory requirements.
- Assess and approve new OEM’s, product specifications and artwork / labelling is in accordance with legal requirements.
- Arrange and/or conduct supplier audits in relation to the company’s GDP and MDR requirements.
- To provide or seek high quality, timely, reliable advice on a range of Regulatory issues including company responsibilities and product information.
- To ensure that the company guidance on current regulations, legislation and best practice.
- To advise and support line managers and employees seeking advice on regulatory requirements.
- To ensure that the company has suitable of Quality Agreements in order to meet regulatory requirements.
- Lead the creation of QMS compliant processes and procedures to further improve the internal governance of our QMS systems, compliance with required
Skills & Experience
- Relevant experience in Medical Device regulatory environment
- Minimum 2yrs experience in a quality managers/Management position
- Detailed knowledge and understanding of Medical Device legislation
- Good knowledge and understanding of ISO13485:2016 and associated standards
- Good working knowledge of product classification for medical devices, specifically selecting appropriate classification, and conformity assessment route.
- Formal Training in ISO13485/ISO9001 auditing (preferable)
- Understanding of foreign regulatory requirements, and introduction of new products to new markets would be advantageous.
What we offer
- Annual bonus, based on company performance
- Free parking on site
- Eye test vouchers and access to an Employee Assistance Programme
- Discount portal including gym memberships, shopping and days out
- Company pension with Aviva and access to a Virtual GP Service
- Company sick pay, life assurance, and enhanced maternity/paternity pay
- Enhanced holiday entitlement – 33 days in total, including bank holidays
Who are DD?
DD offers specialist products, equipment and support services to the dental and beauty markets across the UK and the Republic of Ireland. In 2022, we won Outstanding Business of the Year from the Dental Industry Awards. We are accredited to ISO 9001 and 13485 quality standards and licensed by the MHRA for procuring, supplying and exporting medicinal products. We are rapidly growing and our vision is to become healthcare’s first choice for clinical treatment products and service solutions. Our Quality team is full of energy, with a passion for what they do. So if you have the necessary skills and experience, we look forward to hearing from you.