Main Purpose of Job and Objectives
To work with PPM implementation Project Manager and assigned team to provide complete Planned Preventative Maintenance program for TA Glasgow site installed manufacturing and support area equipment base
Provide Quality Engineering support to the PPM project leader as required to assist in successful completion of project.
Ensure that all project deliverables meet the requirements of all applicable regulatory standards: EC Medical Device Directive (93/42/EEC): ISO 13485; ISO 9001: FDA CFR 21 820, and associated Canadian, Australian, Japanese and Taiwanese regulations.
Ensure that project deliverables are aligned to all internal policies and procedures, local and global
Work towards meeting departmental and facility objectives.
Development of cross functional and collaborative relationships within the facility and across facilities, to aid successful completion of PPM project.
Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business.
Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives
Qualifications and Experience
Relevant Science/Technical Degree or equivalent industry experience.
Proven experience in Quality Management Systems in a similar role within a medical device environment.
Extensive experience in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing.
Extensive experience of project support to engineering and validation teams.
Strong leadership experience including motivational management.
Experience of FDA regulations.
Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices.
Excellent facilitation, coordination, prioritising, presentation and communication skills.
Proven ability to manage and prioritise workload, 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
Must be able to work cross functionally and develop effective relationships in support of project completion
Must be able to influence change with objective information and well-structured communications.