Senior Quality System Engineer - Ireland
Posted on : 10 July 2017
- Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISO13485, FDA QSR.
- The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required.
- This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.
- Also work with the R&D team and being responsible for Medical Product (CE Mark and FDA 510k)
- Design Assurance and Risk Management Activities on individual projects that are assigned.
Duties / Responsibilities
- Coordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.
- Lead preparation and coordination activities for external audits and liaise as required with SME’s to ensure audits are conducted in an efficient manner.
- Manage all aspects of the Document Control Function in conjunction with the appropriate resources.
- Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.
- Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAPAs are completed in a thorough and timely manner.
- Identifies any opportunities for improvement within the quality system procedures and practices in association with the appropriate internal groups.
- Promotes the awareness of regulatory and customer requirements throughout the organization.
- Supports Quality training on site.
- Methodical review approach and be capable of initiating and leading change and continuous improvement.
Previous experience in leading or participating in external notified body or regulatory audits.
Education / Experience
- A degree in Engineering, Technology, or Science
- At least 7 years experience working in a regulated device or pharmaceutical company.
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills
Some of the benefits our employees enjoy:
- VHI including Dental
- On-site Free Parking
- Paid Holidays
- Sports & Social Club
- Flexi- Start Time.