- Develop and implement Quality Management strategy and plans, including resource, systems, timescales, financials, to support, contribute to, and integrate within, the organization’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 QMS effectiveness and input into 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.
- 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. Minium 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 analyze 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 organization.
- 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, analytical & problem-solving skills and to handle multiple tasks.
- Builds strong relationships by fostering open communications, respect and trust.
- High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- Excellent English (both oral and written)