ABOUT THE ROLE
Reporting to the Group Operations Director, the Quality Manager will maintain and oversee all aspects of our Quality systems within TG Eakin, (To include and not limited to ISO 13485, ISO 14001, FDA standards, Medical Device Directive, CE Marking, ISO 14971). The successful applicant will provide clear direction to the Management team within TG Eakin to ensure all processes and systems are fully compliant and work proactively to maintain a programme of continual improvement. The role will suit an individual who can work with a high degree of autonomy and can quickly build effective working relationships.
- Ensure all relevant processes needed for each of our Quality requirements are established, implemented, maintained and under constant review to the required standards
- Help to evolve our current Quality and Regulatory systems to keep pace with a dynamic regulatory environment.
- Report to Management on the performance of the Quality Management system (QMS) and any need for improvement
- Report against agreed quality metrics on a monthly basis
- Investigate relevant Customer complaints and instigate corrective action when required
- Liaise with Managers on all aspects of Quality within the company
- Liaise with the relevant external stakeholders for accreditation purposes / external audits / supplier audits / customer audits.
- Prepare submit and maintain required documents for maintaining all quality systems.
- Assessing all new raw materials used and existing products to ensure regulatory compliance.
- Monitor and review all relevant validation processes and ensure FMEA is conducted
- Create regulatory compliance statements for customers, create and maintain a regulatory database including information on all raw materials, formulation products.
- Review of Technical files
- Responsible for document control
- Ensure internal audit schedule is maintained, following up on all CAPA
- Review the quality of all internal audits and provide timely feedback when required.
- Provide ongoing training and support to managers and internal auditors
- Aid the development and training of cross functional teams in all aspects of QMS and ensure all new starts receive the appropriate induction.
- Management and implementation of all other aspects of Quality requirements not specifically outlined above.
- Ensure the company’s environmental management system is maintained to ensure ongoing compliance with ISO14001:2015.
- Liaise with other group companies to develop management strategies and systems for Health & safety and regulatory compliance.
- Organise and chair regular meetings to discuss Environmental and Health & safety issues and address any issues arising.
- To determine the requirements of the Medical Device Regulations applicable to the company’s operations and ensure compliance.
- To act as the management representative for the company.
- To act as the person responsible for regulatory compliance for TG Eakin and Eakin BV.
- To fulfil the responsibilities of an authorised representative on behalf of Eakin BV.
- Ensure the implementation of a risk management process suitable for the current product portfolio.
- To advise on regulatory requirements for new products and ensure compliance during the NPI process.
- Review and maintain the company’s business continuity plan.
- To advise colleagues and business partners on the regulatory implications of BREXIT and ensure implementation of suitable measures to minimise adverse effects.
- To manage, advise and mentor other members of the Quality department
- To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
- To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
- To adhere to the company’s Quality policy and Environmental policy
- To undertake other duties as may be reasonably required
- Proven experience in a similar role.
- Previous leadership experience.
- Proven track record in ensuring compliance with:
- Medical Device Directive – full Technical File preparation including authoring Clinical Evaluations.
- CE Marking new products.
- FDA QSR 21 CFR part 820
- Experience of managing and developing Quality System requirements in a regulated industry.
- Experience of Risk Management techniques compliant with ISO 14971 including FMEA.
- Implementing and ensuring timely completion of any Corrective or Preventive arising from internal or external audits.
- Excellent communication and interpersonal skills.
- Educated to a Degree standard.
- Experience in the implementation of Environmental standards e.g. REACH, ISO14001 and ideally ISO50001.
- Experience in the implementation of other applicable compliance requirements associated with an international regulated business.
- IRCA certified Lead Auditor qualification.
- Have worked as a Management Representative (ISO13485) and been the point of contact for Notified bodies.
- Process Validation design and implementation.
- Quality Management experience in a Wound Care environment.
KEY WORKING RELATIONSHIPS
- Senior management team members
- Departmental managers
- Employees at all levels
- Notified bodies, competent authorities and other regulatory bodies
- Suppliers and sub-contractors
- Customers and business partners
- People: 2/3 direct reports
- Control of the site quality expense and wage budgets.
- Travel would be required to other group sites, suppliers and customers as required.
Problem solving – Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.
Resilience – Can work under pressure, remains calm, thinks clearly and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and doesn’t dwell on past events.
Team Working – Enjoys participating in group activities and likes to work in close proximity with other people. Is ready to collaborate with and support others and is willing to co-operate and compromise for the overall good.
Analytical – Enjoys analysing qualitative data but also considers quantitative and seeks to identify and explore they key elements in information before making commitments. Tends to like to use facts and figures when planning and reporting and is concerned about accuracy and detail
Information Gathering – Enjoys dealing with and refers to factual data. Likes to be well informed and drills down into details. Prefers to access wide range of information and opinion before making decisions and when solving problems.
Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively
Quality Orientation – Is precise, pays attention to details, checks things and ties up ‘loose ends. Has a strong conscience about getting things right and seeks to ensure that decisions and solutions do not involve undue risk, adheres to policy and standards.
Oral Communication – Talks readily and confidently to people, expressing themselves with obvious ease. Speak out and makes themselves heard, often playing a leading and influential role in debate and discussion.