21605746-QA Specialist-Dublin Contractor

This is a 12-month contract initially.

Purpose:

The Medical Device Combination Product Specialist is to provide quality oversight and support for clinical and commercial combination products from introduction throughout the product and design control lifecycle and the associated Quality System. As a significant quality contributor, the successful candidate will proactively engage with all stakeholders involved with product quality and design control risks through early detection and mitigation during product development and technology transfer. The Medical Device Combination Product Specialist is a member of the Global Quality Organisation and is a quality liaison between Global Product Development (US Based), Manufacturing Operations, Quality Control, and Quality Assurance (US and Ireland) to ensure regulatory compliance with design control activities and documentation, technology transfer to manufacturing and QC testing processes. The role enables efficient communication and decision-making related to the quality and design control of our combination products. The successful candidate shall work in the office a minimum of 3 days per week.

The position reports to the Quality Medical Device Senior Manager and is a member of the Medical Device Quality Team (MDQ).

Responsibilities:

• Support the development of the Design Development Plan in line with applicable regulations for combination products including Planning, Design and Development, Design Verification, Design Validation, Technology Transfer, and Risk Management.
• Responsible for ensuring quality compliance during design transfer from development to manufacturing.
• Provide Quality oversight for the development, review, and approval of key Design History File deliverables including Verification and Validation Protocols and Reports, Risk Management deliverables, Transfer Plans, Design Reviews, Design History File management, and supporting operational procedures.
• Provide Quality Engineering input on developing CTQ criteria and specifications for Combination product raw materials, in-process, and finished product acceptance activities as required
• Facilitates global and local changes with respect to product and design control
• Ensure timely entry, processing, and closure of quality records in compliance with company procedures.
• Liaise with third parties such as device constituent partner manufacturers related to device-related investigation outcomes and root cause assessments.
• Support documenting and periodic review of supplier quality requirements and supplier quality agreements.
• Partner with Quality Scaled Digital Services (QSDS) to ensure successful deployment of a combination product Quality Management System
• Support risk assessments relating to the batch release or product quality for clinical and commercial products.
• Supports Notified Body and Health Authority inspections and compliance.
• Ability to work cross-functionally with Development, Tech Ops, Regulatory Affairs, and Quality Assurance.
•  Communicate effectively, both verbally and in writing, internally across departments and with external partners.
• Comply with the company’s quality assurance requirements as well as applicable regulatory requirements.
•  Other duties as assigned.

Requirements:

• B.Sc. / B Eng degree in Engineering or Science or equivalent experience in a regulated industry.
• Knowledge of the regulatory and compliance requirements of design control for medical devices and/or combination products (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and Regulation (EU) 2017/745).
• Preferable 4 years +’ cGMP experience within the quality in a medical device, combination product R& D, or manufacturing environment, ideally clinical phases through commercial
• Understanding of Medical device development for the full lifecycle starting at the Design Control phases
• Demonstrated ability in decision-making, problem-solving, and project management.
• Excellent communication and interpersonal skills
• Experience in pharmaceuticals and combination product and device delivery systems.
• Knowledge of process development and quality systems with strong business and technical acumen would be an advantage.