A Quality Systems Analyst (Maternity Leave) is required by CareerWise Recruitment for our Galway based client. The current incumbent is due to finish for their Maternity leave towards the end of December so, to allow for sufficient handover, I would really need the candidate to be available to start on or before November 18th. This role will require a systematic and thorough approach to robust Quality System implementation, and cooperation with all functional teams in order to support the maintenance of an effective Quality System.
Please contact Tom Devaney for more information.
Role of this position
- Coordination and Management of Quality System Records relating to Document Control, Training, Deviations, Non-Conforming Material Reports (NCMRs), Corrective & Preventive Action (CAPA), Internal Audit, etc.
- Management of Quality System Metrics to support the Corporate QHS initiatives.
- Participate and lead, where relevant, the on-going development of both Corporate and site level Quality Systems.
- Lead or participate in Internal Audits to assess compliance to Regulatory and Quality Management System procedure requirements.
- Provide timely issuance of Internal Audit reports and/ or CAPAs.
- Provide timely follow-up on Audit responses and Corrective Actions, and track completion of activities from scheduling through to audit closure.
- Devise or revise Standard Operating Procedures relating to various quality system elements.
- Provide Quality System support to Manufacturing, Engineering, Supply Chain, Human Resources and Warehouse.
- Provide support for Root Cause Investigations, relating to NCMR and CAPA proposals and initiatives.
- Be the Subject Matter Expert for the Quality department on software integrations that affect the Quality System, such as SAP, Trackwise, etc.
- Bachelor's Degree in Science, Engineering (mechanical, industrial, chemical, electrical) or equivalent discipline is preferred.
- Minimum 3 years of Medical Device Quality experience in an ISO/ FDA regulated manufacturing environment....5 or more years of experience preferred.
- Document Control experience is essential.
- Competent using office software including MS Word, Excel, Internet Explorer, Powerpoint and Outlook. ......Experience working with Compliance Wire is preferred.
- Strong knowledge and understanding of FDA regulations (21CFR 820), ISO13485 and other ISO standards related to Medical Device manufacturing as required by the position.
- Ability to focus on and achieve scheduled milestones, including contingency planning.
- Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
- Ability to travel up to 25% of the time, both domestically and internationally.
- Ability to read, analyze, and interpret engineering specifications, general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, specifications, business correspondence, and procedure manuals in English.
- Ability to effectively present information and respond to questions from groups of managers, clients, and customers.
- Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)