Purpose of the role:

Reporting to the Operations Director, and with a dotted line into the Snr Quality Director-Europe, the Quality Manager leads activities to ensure that our Quality Management Systems and Manufacturing Quality meet company and regulatory requirements. The Quality Manager will work alongside all other members of the Site Leadership Team to achieve the site's key performance metrics and deliver its strategic objectives.

Specific responsibilities:

• Develop and implement Quality Management strategy and plans, including resource, systems, timescales, financials, to support, contribute to, and integrate within, the organisation's annual business plan and long-term strategy.
• Develop, sustain and continuously improve the QMS in accordance with Company procedures and regulatory requirements. (ISO 9001, BRC/ISO standards, GMP/GDP, Customer Codes of Practice, HACCP Level 4)
• Act as site Management Representative responsible for the Planning and execution of Management Review activities, including tracking and closure of action items.
• Identify and manage the Quality Budget, ensuring the reduction in risk from claims and all potential costs.
• Identify, develop, and report QMS trending, metrics and KPIs. Enabling the Elsham leadership team to have oversight of FM'S effectiveness and input into Elsham priorities and objectives.
• Provide effective and timely communication of product quality issues, to ensure mitigation of risk
• Responsible for the timely processing and closure of customer feedback through the QMS Complaint process, escalating critical issues as appropriate.
• Drive robust timely and effective corrective and preventive action programs through the CAPA system ensuring the use of appropriate problem-solving tools.
• Develop and maintain internal audit program, lead and support third party audit.
• Play an active role in the execution of projects identified to drive quality systems effectiveness.
• Drive continuous improvement (BPI) initiatives to enhance the Site Quality System and ensure compliance to Corporate policies and procedures.
• Develop and maintain systems to establish standards relating to activities and products.
• Develop and maintain systems to measure performance against established standards.
• Monitor performance (in relevant areas) according to agreed standards and take necessary action to communicate/advise/assist according to performance levels.
• Monitor and inform/communicate/apply standards created/maintained by external bodies, and integrate within internal quality management systems.
• Establish and implement necessary communication strategies for the improvement and awareness of quality issues across all departments.
• Manage Quality team according to company standards (appraisals, discipline, training, development, etc.).
• Manage Quality departmental performance against agreed targets and budgets, and within policies and standards.
• Liaise with customers and suppliers (where impacting/affected by quality issues)
• Create programs improving efficiency and quality in day-to-day operations within the facility.
• Key SME ensuring compliance to Change control requirements, leading collaboratively and driving documented and timely change control within the business QMS.
• Quality authority in disposition of quality related customer issues and material issues/defects.
• Promote a culture of Quality first, ensuring continued focus on the developing awareness and positive engagement of all employees towards the continued improvement of Quality.
• Develop and conduct effective training programs on related QA topics for both Quality and non-quality employees. (e.g. Employee quality Induction/ refresher program, GDP/GMP/ Regulatory awareness)
• Liaise with Snr Director of Quality Europe and other Quality Managers to implement Quality Improvement and Assurance activities across the organisation's
• Performs other duties as assigned. Will include participating in special projects as identified.

Knowledge, Skills and Experience Required:

• Degree in Engineering or Science discipline, or equivalent. Minimum of 10 years work experience in Quality technical role, latterly in a Quality Management position in the Medical, Pharmaceutical, Bio-Medical or automotive environment.
• Excellent Management and leadership skills. Minimum of 3 years leadership experience in a Quality leadership role, preferably within the Medical Device sector.
• Working knowledge of quality tools such as SPC/Process control, FMEA/Risk, Problem solving/Root cause Analysis, Pole-Yoke and other six-sigma tools. Six-Sigma training an advantage. An aptitude to analyse data and create/revise QMS processes
• Ability to be the voice of Quality when dealing cross functionally, will take the lead discussions / meetings to ensure the correct outcome.
• Must be able to work within a team in a dynamic environment and interact effectively at all levels and across all functions within the organisation's.
• Proven track record of successfully creating and managing a highly talented, engaged and performing team.
• Mentoring, coaching and performance management
• Experience in interacting with regulatory agencies advantageous.
• Strong verbal, written, and interpersonal skills
• Self-starter with ability to exhibit efficient work methods, analytic & problem-solving skills and to handle multiple tasks.

About Us

We are dedicated to fostering a diverse and inclusive community. In line with our Diversity and Inclusion policy, we welcome applications from all qualified individuals, regardless of age, gender, ethnicity, sexual orientation, or disability. As a Disability Confident Employer, and part of the Nicholas Associates Group, we are committed to supporting candidates with disabilities, and we're happy to discuss flexible working options.

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