Description
I have an excellent opening for a Quality Assurance Specialist with an exciting medical device company based in Dublin.I am seeking a Quality Assurance Specialist, who will thrive in a fast paced start-up environment, to take responsibility for key aspects of product quality assurance, manufacturing quality control documentation of existing & new products, ensuring safe product release, and support successful new product registrations. The role will also involve supporting process development, scale-up production, and manufacturing at the pilot manufacturing facility in Dublin and at its contract manufacturing facility.
Key Responsibilities
* Manage Document and Change Control, CAPA & NC systems.
* Manage Internal Audit system, performing internal & vendor audits where required
* Assist in Vendor Management activities such as vendor file management and updates
* Manage and monitor Training system
* Assist with key regulatory activities: customer complaints, product registration, vigilance reporting as required
* Creation and ongoing review of QMS documentation associated with the manufacturing facility, highlighting any gaps encountered.
* Review and approval of all validation protocols/reports and associated documentation Responsible for scheduling & approval of equipment preventative maintenance activities with the cGMP manufacturing facilities.
* Ensure validation protocols and associated engineering validation runs are in compliance with ISO 13485 and FDA QSRs.
* Quality Review and sign off of all IQs, OQs, PQs/PPQs/VMP for all equipment and processes within the plant, including pre- & post-production quality documentation approval.
* Responsible for incoming inspections/product release of all raw materials associated with manufacture and packaging of the products associated with the plant. Support the creation & maintenance of product Design History Files and Design Dossier's.
* Manage process FMEA and risk management files.
* Support production scale-up activities, ensuring compliance with Quality Management System (QMS).
* Responsible for review and approval of outsourced manufacturing processes (Certificates of compliance and testing certificates).
Education, Skills and Experience
The ideal candidate will have:
* Minimum of a Certificate in Quality Management/Regulatory Compliance (or equivalent) in a science or engineering related discipline and 2-4 years' Quality Assurance experience in the Medical Device industry.
* Lead Auditor qualification (preferable)
* Experience in medical device quality & regulatory systems (ISO13485 and FDA 21 CFR 820) and EU medical device directives.
* Experience in the ongoing management of medical device CE mark and FDA regulatory submissions a distinct advantage.
* Proven project leadership abilities.
* Proven track record in delivering quality results in a timely effective manner in a team based environment.
* Good understanding and experience of Good Manufacturing Practice (GMP) principles and implementation
* Strong technical, analytical, problem solving and decision making skills
* Prior experience with implantable medical device development a distinct advantage
* Knowledge of supplier/vendor control systems a distinct advantage.
* Excellent interpersonal and communications skills, with a proven track record of successfully working as a member of a team ability to develop strong working relationships.
This is a brilliant opportunity to join a growing company that will offer excellent upskilling opportunities and fantastic experience for career progression. If you are interested in this role please respond with an updated CV or contact Derek Sheridan on for immediate consideration.