Senior Quality Compliance Engineer - Based Glasgow




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Reference: 6231

Evolve Selection are currently recruiting for an exciting new opportunity with a dynamic and supportive Healthcare organisation. Our client has an extensive product range within the Vascular market. This exciting role will be working as a Senior Quality Compliance Engineer based in Glasgow. The main purpose of this role is to support key QA processes to ensure compliance with required regulations and company policies and procedures.

Relevant Science/Engineering Degree, or similar qualification.
Proven experience in Quality Management Systems in a similar role within a Medical Devices or a similar regulated environment.
Lead or Internal auditor qualified with proven audit experience.
Strong analytical and problem-solving skills.
Knowledge and experience of FDA regulations.
Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for Medical Devices.
Excellent facilitation, coordination, prioritisation, presentation and communication skills.
Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment.
Competence in the use of IT technology, such as Microsoft Office applications, and ability to learn other IT systems used in the QA department.

Role Responsibilities:
Support and manage the coordination of external audits by OEM customers and regulatory bodies including leading advanced preparation of all notified audits, developing a process for managing of unannounced audits, responding to any identified findings from customer / regulatory audits, following up on audit findings and tracking through to completion and ensuring site audit readiness always.
Support and coordination of company internal audit programme including management of internal audit schedule, trending and reporting of internal audit findings, and performing Internal Audits as required.
Provide trending data and reports upon request to senior management, Functional Managers, regulatory authorities and customers.
Work towards meeting departmental and facility objectives.
Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business.
Oversight of new and updated quality and regulatory requirements to ensure the site retains a state of compliance in a changing environment.

Role Specific Competencies:
IT literate with strong analytical skills.
Flexible “can do” attitude needed to thrive in a fast-growing company.
Innovation, tenacity and drive to ensure success.
Self-motivation, persuasiveness and competitiveness.

Recruitment Process:
2 stage process.

Flexible salary and benefits DOE.

Evolve Selection is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions.

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