Quality Assurance - Chepstow, United Kingdom - Creo Medical

Description

About the role

Under the direction of and working closely with the Head of Quality Assurance this role will support the development, implementation, monitoring, and maintenance of the Quality Management System in a fast-growing medical devices company.

The role will ensure policies, procedures, and reports are compliant with the appropriate state-of-the-art regulatory requirements worldwide.

The role will have a global reach in an organisation that has a footprint in many markets primarily delivering electrosurgical generators, disposable instruments, and service support.

The role requires an excellent knowledge of medical device quality system standards, and an ability to work across functions to bring the organisation together and develop a consistent QM.

Key Responsibilities

Implement the quality systems development programme for the organization and to develop procedures that are compliant with the requirements of appropriate regulatory authorities.

This will require close collaboration with process owners.

For new or changed procedures ensure that:

• There is effective coordination with process owners and sister organisations, including Spain/Germany/US.
• Changes are appropriately validated before implementation to avoid error and correction.
• Process owners have appropriate training in place prior to release
• Support the planning and implementation of the internal audit program. Develop the process and personnel necessary to implement efficient, riskbased audits that drive continuous improvement.
• Support the internal audit process and liaise with consultants and internal auditors as required.
• Management of the Nonconformance process to drive best practice and progress to closure.
• Weekly internal audit of the operations processes and practices.
• Monitor and perform periodic reviews of quality system procedures to ensure compliance with both regulatory and internal requirements.
• Support sister companies in compliance activities.
• Provide regulatory and quality systems training
• Support the external audit process and support "backroom" activities to facilitate an efficient and professional audit process.
• Lead quality supplier audits.
• Support CAPA activities as required.
• Perform other duties as deemed appropriate for the role.

What we are looking for:

• Must have previous experience in either a Quality Engineering, Quality Assurance or Regulatory role with medical devices or a related healthcare discipline.
• Must have an appreciation of the impact the following standards and regulations have on the QMS i.e. MDR 2017/745, ISO 13485 and/or FDA 21 CFR part 820.
• Ability to communicate effectively, and credibly, with all colleagues and stakeholders (internal & external).
• Strong interpersonal, written, and verbal communication skills
• Ability to manage others.
• Good understanding of sterilization methods and regulatory requirements
• Excellent organisation and prioritisation skills
• A strong sense of urgency to make things happen to get results.
• Ability to work independently as well as a team member in a fastpaced, time sensitive, constantly changing environment
• An ability to use general office software (Microsoft Office) and other specialised software (e.g. online resource tools and databases).
• Reliable

About us

Anything is possible with the right approach

Engagement and collaboration are key to our business success and to continually innovate and exchange ideas and knowledge in an open, encouraging, and developmental environment whilst we challenge the status quo.

Being part of our team will mean making a real difference globally

With a passion for improving healthcare, our products are used to treat patients in multiple countries and so we continue to expand our team to introduce different experience into the design, manufacture, production, and commercialisation of electrosurgical medical devices, ultimately impacting and being part of an extraordinary journey.

Salary:
£45,000.00 per year


Benefits:

• Company pension

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Chepstow: reliably commute or plan to relocate before starting work (required)

Work authorisation:

• United Kingdom (required)

Work Location:
In person

Application deadline: 08/12/2023