An exciting opportunity has arisen for a Head of Quality within the medical device manufacturing industry, based in the Wallasey area.
About the Role:
Our client is seeking a highly skilled and detail-oriented Head of Quality to lead both the Quality Assurance (QA) and Quality Control (QC) teams.
This hybrid position will focus on:
*Ensuring compliance with quality standards and procedures across all manufacturing processes (QA focus)
*Leading and managing the day-to-day operations of the QC team to support operational excellence
Please note: This role does not have responsibility for the Quality Management System (QMS).
Education and Experience
The successful candidate will hold a BSc and MSc in Chemistry, Biochemistry, or a related discipline, along with several years of experience in a QC/QA environment.
Key Responsibilities:
Quality Assurance (QA)
*Monitor, assess, and verify compliance of manufacturing processes with established quality standards.
*Conduct audits, identify gaps, implement corrective actions, and drive a culture of continuous improvement.
*Support the understanding across the site of CAPA’s, their importance. Collaborating with production, engineering and supply-chain teams to resolve quality-related issues and implement corrective and preventative actions (CAPA’s)
*Develop and maintain QA documentation, including inspection protocols, test plans, and quality reports.
*Train operational staff on quality standards and best practice.
*Monitor and report on key metrics, develop interval reports and recommendations.
*Assist in supplier quality assessments and incoming raw material inspections
*Develop a culture of CI aimed at reducing waste, increasing efficiencies and enhancing product consistency.
Quality Control (QC)
*Lead, coach, develop, and mentor the Quality Assurance and Control team to ensure optimal performance.
*Actively support and promote the transition of in-line process control to our Production teams.
*Schedule and co-ordinate daily QC activities to align with production demands and deadlines
*Ensure proper use, calibration and maintenance of all testing equipment and tools used by the QC team.
*Review and approve inspection results, none-conformance reports and product release documentation.
*Develop and embed SOP’s/BMR’s
*Collaborate closely with Production, R&D, and Compliance teams to align quality initiatives with business goals.
*Stay updated on relevant industry regulations and ensure company compliance.
Key Requirements:
*Strong knowledge of QA/QC processes, inspection techniques, and root cause analysis tools.
*Strong leadership and people management skills, with a track record of building and motivating high-performing teams.
*Strong working knowledge of QA/QC processes, inspection techniques and root-cause analysis
*Familiarity with regulatory requirements and industry standards (eg ISO, GMP)
*Excellent communication, problem-solving, and decision-making skills.
*Ability to manage multiple priorities and work under pressure.
Our client Offer:
Benefits:
*Competitive salary and bonus structure
*Factory close-down at Christmas
*25 days annual holiday entitlement 1 gifted company day
*Option to purchase 3 additional days annual leave
*Pension plan
*Simply health and Unum Help at hand
*Free parking
*Professional development and training opportunities
*Cycle to work scheme
Full-Time / Permanent / Hours of work Monday- Thursday 8am -5pm and Friday 8am -12.30pm
All applicants must be living in the UK and eligible to work.