Quality Manager

Job Details

• This role has direct responsibility for managing the day-to-day quality activities for the Plymouth site and ensuring teams are in place with the correct skill sets and experience to ensure compliance and patient safety.
• Directly supporting site operations and R&D to manufacture and develop right first time, high quality products and processes, ensuring compliance with the applicable requirements of cGMP, FDA QMSR 21 CFR 820, ISO13485 and European Medical Devices Directive/Regulations and all other applicable regulations/standards.
• To assure necessary compliance requirements through the Quality Management System including continuous improvement, CAPA management, document management, quality planning, internal and external audits, validation, risk management, and continuous Quality Management Review.
• Assume the role of Management Representative for the Plymouth site.

What this role will involve:

• This position has responsibility of the site quality team at the Plymouth site, which includes, quality systems, quality engineering and QC where required.
• To support the maintenance and improvement of the site quality management system to comply with the requirements of MDR and MDSAP regulations and Group procedures where applicable.
• Drive the successful execution and implementation of applicable Quality strategies.
• To ensure site Quality team are well trained and motivated in doing work.
• Prepare and manage budget for the site quality function.
• Act as site Management representative, where required.
• As part of site Operations management team, establish and manage quality improvement projects in accordance with company objectives.
• To ensure adequate support to ensure effective delivery of new product development. Responsible for the quality deliverables of NPD products and that they are designed and developed in compliance with design control and validation requirements.
• Maintain quality management system certification.
• Responsible for the continuous improvement of the Quality management system.
• Responsible for decision making related to quality issues. Root cause analysis and re-medical action. Avoidance of any Product recalls.

What we're looking for?

• BSc or equivalent in scientific discipline or the abilities that are typically acquired through a minimum of 4+ years’ experience in medical device or pharmaceutical industries.
• Demonstrate leadership experience in previous roles.
• Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements.
• Knowledge of the Medical Device regulation.
• Proficient in knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
• Proficient in spreadsheets and word processor applications.
• Proficient in concepts of statistics, sampling plans and statistical analysis.
• Proficient in analytical methods, equipment, process, software, cleaning and/or facility/utility validations.
• Ability to independently plan, execute, and/or problem solve moderate to complex situations.
• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Solid oral and written communication skills.
• Ability to manage multiple projects.
• Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation.
• Computer literate - knowledge of Word, PowerPoint and Excel an advantage - to produce reports, analyse data etc. effectively.