To drive the day-to-day implementation of the QMS with a focus on continuous improvement. Support manufacturing, supply chain, and design assurance activities. Represent the quality function cross-functionally.
Knowledge & Education:
* Bachelor’s Degree in Engineering, Science or related field
* 3+ years’ experience in medical device quality/design assurance role
* Recent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive and other applicable national and international regulations and standards
* Master’s Degree in Engineering, Science or related field
* Experience with implantable medical devices
* Experience with process development and change management in a regulated environment
* Exceptional attention to detail
* Well organised with ability to work to deadlines
* An aptitude for identifying & implementing process improvements
* Ability to proactively identify issues and make recommendations
* Proven ability to function efficiently in a fast-paced environment with multiple and shifting priorities
Responsibilities/Key Objectives:
Drive the day-to-day implementation of the QMS.
Ensure delivery of overall quality strategy & support achievement of the business quality objectives.
Collaborate with the wider team to ensure necessary QA activities are planned, executed, and documented.
Interpret relevant standards and ensure the company meets requirements.
Develop and review test specifications, part specifications & design specifications with the cross-functional team.
Support manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification, process validation, and change control.
Provide practical QA and Design Assurance expertise.
Support supply chain in supplier-related activities e.g. process development and manufacturing requirements.
Coordinate and manage key activities such as internal audit programme, material review board, NC/CAPA review board, complaint process.
Project support for regulatory submissions.
Support clinical investigations.
Ad hoc duties as required.
#J-18808-Ljbffr