Quality Systems Manager

Job Description

Job Description

A Quality System Manager is responsible for developing the Quality strategy, policies, processes, standards and systems for the Company and its supply chain to operate within. This may include auditing to ensure compliance with third party accredited bodies. 

Overall Roles:

- Develop and sustain the Quality Management System in line with the required industry standards (including: TS16949, ISO14001 / ISO 9001 / ISO 13485 / ISO 45001), accreditation requirements and business requirements across the organization through existing and new procedures. Regulate, control and improve the quality of all processes throughout the business and the final product. Manage the audit program to ensure that all nonconformities raised against certification bodies during audits are effectively corrected and independently verified. Embed a culture of continuous improvement throughout the company. Lead the team to achieve quality management system targets for customers and business goals. 

 

- Key Responsibilities:

- Develop the Management Systems strategy and the management arrangements for key milestones, demonstrating solid progress against plan

- Manage all external registration requirements to ensure they are met. Liaise with external bodies on all matters relating to registration. Maintain and improve, in line with business needs

- Implement all relevant procedures described in the Quality Management System (QMS)

- Ensure that all in-house systems and procedures are updated, revised and modified to meet the needs of external certification bodies

- Update quality documentation and communicate to carry forward lessons learned from quality concerns 

- Introduce new systems and procedures where appropriate

- Train others in all aspects of the quality system and application of procedures

- Undertake regular internal and process audits of the QMS

- Ensure corrective actions are undertaken to address non conformities found

- Verify closure of non conformities with Certification Bodies 

- Hold quarterly audit performance meetings within the Company

- Manage the audit nonconformity data base

- Provide detailed analysis of nonconformities 

- Ensure ongoing compliance with the Quality Management System (ISO13485/ISO9001)

- Undertake continuous training and development

- Identify business improvement opportunities within the organization

- Develop, implement and manage key performance indicators (KPIs) for each area of responsibility

- Set department objectives/KPIs and review and assess ongoing performance of direct reports

- Ensure KPIs are met by working to the overall plan, including management of, and reporting 

- Report on achievement of targets and identify any actions required

- Ensure that the function operates in accordance with any health, safety and environmental policies and procedures to ensure the safety and wellbeing of staff and visitors

- Conduct risk assessments of processes and tasks in the department People Management

- Manage, coach and develop a high performing Quality System team that meets agreed objectives and which delivers best practice results, added value and continuous improvements

- Review, implement and update company records e.g. training matrices, performance reviews, risk assessments

- Work as part of the Management team to share ideas and improve operation, recommending, supporting and implementing continuous improvement activities and process and procedure improvements to optimize results and improve quality of delivery, in line with quality standards requirements delivery in line with Company and Customer requirements

- need to work on FA samples submission and PPAP document

- Comply with the Health, Safety and Environmental Policies 

- Proactively contribute to creating a good team atmosphere

- Takes ownership for team cohesion and team development

- A self-starter, motivated and able to positively motivate others

- Focused, target driven with a positive, can-do attitude Skills and Attributes:

- A detailed understanding of ISO13485, ISO14001, ISO 9001