As the Quality Systems Manager, you will provide hands-on leadership to the rest of the organisation in terms of quality systems, knowledge, compliance and training. You will provide strategic project direction and ensure that regulations, standards and requirements as implemented are up-to-date, identify compliance gaps and take action to address them.
You will work closely with the Operations and R&D teams to drive and grow the business to meet the strategic objectives of the organisation.
Role & Responsibilities:
- Lead and Manage the Company’s Quality Management Systems in line with FDA, MDR and ISO 13485 requirements, leading to relevant certifications. This includes but is not limited to the following responsibilities:
- Manage the Company’s electronic QMS System.
- Maintain the Company’s training system.
- Manage suppliers, including supplier selection, auditing, and quality agreements.
- Responsible for purchasing controls, including quotes, PO’s, invoices, and payments.
- Manage the document control system, including control of records.
- Leading Management Reviews and Quarterly Review Meetings.
- Documentation of internal audits.
- Control of non-conforming and CAPA system.
- Management and control of product complaint management system.
- Responsible for post market surveillance systems.
- Leading continuous improvement systems.
- Pro-active lead on external audits (Regulatory Agency and Notified Body) and co-ordinate such activities as required.
- Ensure that the product development outputs are aligned with the appropriate standards and requirements and provide design assurance inputs and reviews. This includes but is not limited to the following duties:
- Maintain Design History Files.
- Performance of documentation reviews for design control documents and QMS documents in general.
- Material contribution to the risk management process.
- Co-ordination of design reviews.
- Manage, support and co-ordinate with Regulatory Consultants and other Consultants to support the business needs.
- Be a core member of the management team, feeding into the company’s goals and business strategies.
- Proactively drive a quality culture within the organisation.
Management Representative/Person Responsible for Regulatory Compliance
The Quality Manager is the company’s Management Representative and will ensure that the quality system is established, implemented, and maintained in accordance with FDA and ISO 13485. These requirements include but are not limited to:
- Ensuring that processes needed for the quality management system are documented.
- Pro-active reporting to senior management on the effectiveness of the quality management system and any need for improvement.
- Promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Taking appropriate responsibility for the product per Article 15 MDR 2017/745.
Key Qualifications, Experience & Skills Required for the Role
- A Bachelor’s degree in Engineering or Science related field.
- Minimum 10 years of quality management experience or equivalent in the medical device industry and/or an FDA regulated environment.
- Must have experience in people leadership.
- Solid quality and systems background.
- Demonstrated knowledge and application of Design Controls.
- Excellent knowledge of Quality Assurance.
- Exceptional leadership and technical competencies.
- Excellent communication skills, including the ability to communicate to all levels of an organisation.
- Good analytical and problem-solving skills.
- Demonstrated ability to collaborate with cross functional teams to ensure business success and ensuring compliance.
- Strong leadership skills, including influencing and team development skills.
- Thorough knowledge of QSR and ISO quality system requirements.
- Good understanding of MDR 2017/745.
Applications to be emailed to email@example.com