Device Quality Specialist

Job DescriptionThis is what you will do: The Medical Device Combination Product Specialist is to provide quality support and oversight for combination products including change control, CAPA and QMS records generated during lifecycle management. The Medical Device Combination Product Specialist is a member of the Global Quality Organisation who is a quality liason between Medical Device Quality, QC, Operations Quality, Central Quality, Supplier Quality including CMOs. The role enables efficient communication and decision making related to the quality compliance of our combination products.

The successful candidate shall work in the office a minimum of 3 days per week. The position reports into the Quality Medical Device Associate Director and is a member of the Medical Device Quality Team (MDQ). You will be responsible for: Supporting the Medical Device Quality Team in progressing the update and release of documents & records in the document management system.

Supports Combination Product Audit readiness initiatives and support during audits. Supports Notified Body and Health Authority inspections and compliance. Responsible for collection/collation of QMS data and performing data analysis to support periodic Combination Product Management Review reports, meetings, minutes and actions.

Supporting weekly/monthly/quarterly QMS governance reporting. Support cross functional teams with review board meetings (e.g. Change control, Supplier Change, change planning, Standards review planning, risk review) and Supplier Quality Agreement updates.

Supporting action includes coordination of review meetings including documenting minutes & actions and filing of records. Ensure timely entry, processing, and closure of quality records in compliance with Alexion's procedures. Attending site team meetings relating to operations activity to ensure quality compliance for combination products.

Support Deviation / CAPA processes by providing oversight of content for compliance, supporting owners in initiating CAPAs and completing action tasks per SOPs to completion on time. Support change control initiators to ensure change control documentation meets combination product regulations per SOPs. Ensure change control documentation including impact assessments are ready and adequate for approval at Change Control Review Board.

Liaise with third parties such as device constituent partner manufacturers related to device related investigation outcomes and root cause assessments. Partner with Quality partners to maintain and improve the combination product Quality Management System. Communicate effectively, both verbally and in writing, internally across departments and with external partners.

Comply with the Alexion's quality assurance requirements as well as applicable regulatory requirements. Other duties as assigned. You will need to have: Minimum of a bachelors degreeor equivalent experience in a regulated industry.

Knowledge of the regulatory and compliance requirements for medical devices and/or combination products (e.g. FDA QMSR 21 CFR Part 820 and Part 4 / ISO 13485 and Regulation (EU) 2017/745), ISO 14971. Experience using electronic QMS / document management systems (e.g., Veeva Vault) for document lifecycle, quality events, and action tracking.

Demonstrated experience managing quality or compliance-related projects in a regulated medical device and/or combination product environment. Proven ability to plan, track, and deliver projects while maintaining focus on compliance, quality, and timelines. Experience applying a structured, risk-based approach to continuous improvement within a Quality Management System.

Excellent communication and interpersonal skills We would prefer for you to have: Knowledge of quality systems with a strong technical acumen would be an advantage. Preferable 4 years +' cGMP experience within quality in a medical device, combination product R&D or manufacturing environment. Experience and knowledge of 6 Sigma methodology, preferably green belt certified.

Skills: QMS CAPA GMP R&D TPBN1_IJ