Our client, a leader in the Healthcare market globally are looking to add a Senior Quality Operations Manager to their Centre of Excellence site based here in Galway. We are looking for an experienced and enthusiastic Senior Quality Ops Manager who can not only implement Quality programs but also be apart of the strategy development and over all leadership team.
- Reporting to the Director of Quality Operations IDEM, the Quality Operations Manager role will provide oversight on all quality operations activities within IDEM.
- Act as the key connection/communication point between site QA teams and the business unit teams for quality.
- Develop a continuous improvement mindset as a key skill across our clients quality community and ensure a standard approach to problem solving.
- Lead and execute specific quality projects within our clients QA function as well as being primary point of contact for all Corporate and Divisional quality projects.
- Provides point of escalation for Quality impacting business operations.
- Quality oversight for Validation (process, equipment, computer systems).
- Quality oversight for raw materials, packaging components, in-process product and supplier qualification.
- Quality support for the introduction of new products.
- Provides QA technical direction and guidance to achieve overall business objectives.
- Operates with business latitude and quality focus. Determines and develops approaches to solutions where situations may have little or no precedent, with new and expanding business operations.
- Makes prompt and sound decisions under conditions of uncertainty, that produce effective end results. Applies risk assessment techniques in such circumstances.
- Drives business improvements through management, mentoring and support of the QA Operations Team.
Education & Competencies:
- Third Level Qualification in related field (Science, engineering or nursing preferable)
- Minimum 8 years of experience in medical device industry with minimum 3 years of progressively responsible positions, including;
- Competent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
- Experience working in electronic complaint management systems
- Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness.
- Pro-active attitude, excellent organization skills, and ability to manage multiple projects while delivering results on time.
- Excellent computer skills including all MS Office applications
- Proficient with MS Word, Excel, Power Point, and management of spreadsheets.
- Able to travel internationally (approximately 15% annually).
For more information on this role and a confidential discussion please contact Christopher O Toole.