CAPU Search has partnered with a Contract Design Manufacturing Organisation in Oxfordshire that is looking to hire a Head of Quality on a permanent basis. This is a dual strategic and hands-on position where you will get to shape the quality function. Over the next 24 months, you will be instrumental in helping the company transition into a fully scaled-up professional production environment, which will naturally lead to growth within the company.

Technology: Biomaterials for use in tissue-regenerative devices

Location: Oxfordshire

Salary: £70,000 - £80,000 negotiable

Company details:

• 25 people
• 50/50 gender split
• 10 nationalities
• ISO 13485 accredited

Role overview:

A Head of Quality to provide leadership in an exciting company that is developing and manufacturing medical device components for multiple clients using novel technology.

The successful candidate will lead the Quality function within the Company, ensuring successful implementation and maintenance of quality management systems and regulatory compliance. They will work with the senior management team, inputting on the development of innovative manufacturing processes and strategies for our medical device technologies in accordance with regulatory requirements, and will liaise with customer Quality departments to align approaches. They will work closely with process validation, scale-up, and manufacturing teams to ensure that the company is operating at an excellent level of Quality with absolute confidence in the products manufactured and supplied to customers.

The Company is growing and evolving so you will need to constantly review Quality strategy and processes to ensure they are fit for purpose. There will be a lot of doing as well as managing.

Main responsibilities

• Provide strategic leadership on Quality, consistent with the Company's growth strategy.
• Ensure all activities are performed in accordance with ISO 13485 and any relevant regulations or Company procedures.
• Ensure that all product released to clients meets internal and external specifications and is of high quality.
• Implement industry best practices for quality management systems.
• Manage the Quality team (currently quality manager, quality officer plus two QC technicians); motivate, coach, and manage performance.
• Manage the quality management system functions of document control, change control, internal auditing, non-conformance control, root cause analysis, corrective and preventive actions, deviations, and management review. Actively support timely closure of CAPAs, complaints & audit actions.
• Lead medical device risk management activities.
• Provide Quality leadership to the verification and validation programs to ensure that processes are in compliance with international regulations (as appropriate), are robust, and commercially sensible. Work closely with these teams on process developments and improvements and analyse process stability and capability.
• Lead and support Company external audits (customer and regulatory).
• The main point of contact for external quality and regulatory communications, including complaint resolution, advice, feedback, and support.
• Reviewing process, product, and facility data for trends and implementing improvements or corrective actions where necessary.
• Training of staff in quality and regulatory best practices.

Requirements:

• At least 5 years medical device experience, including experience in implementing and maintaining quality management systems
• Authoritative knowledge of ISO 13485 including internal auditing experience (qualified lead auditor for ISO 13485)
• Managing people and working collaboratively and productively with colleagues, customers, external consultants, and other stakeholders in different geographical locations
• Appetite to work in a small company environment and to be hands-on
• Relevant degree in science or engineering
• Experience with equipment, facility, utility, test method, and process validation
• Six sigma or similar experience
• Knowledge of medical device regulations (CE mark, UKCA mark, PMA, 510K)
• Knowledge of cleanroom requirements

Desired but not essential:

• Validation experience

Personal Traits:

• Hands-on (a blend of strategy and doing the work)
• Leadership skills to manage a small team
• Transparency: communicating openly and highlighting issues promptly.

For more information, you can reach me via:

???? nathan.puxty@capusearch.com

???? 07742773353

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