- Reference: SJ44259x
- Job Type: Contract
- Location: Leitrim, Mayo, Sligo
- Category: Engineering, Technical & Manufacturing
Senior Quality Engineer – Sligo (Contract)
As a key function of the Department for Compliance & Validation the Senior Quality Engineer is responsible for providing quality assurance support to product and process development activities, including activities managed through change control process.
The Senior Quality Engineer must also provide support to ensure compliance with applicable standards, regulations and Group processes. Strong Regulatory Affairs element to this role.
Knowledgeable, disciplined and experienced enough to play a key role in the deployment of Product & Process Design & Development
Team player to communicate and share good practices with QA Dept Team and other functions
Focused on the patient safety, customer, product performance,
Tenacious commitment to comply with applicable requirements and good practices
Ready to provide adequate support to Project Team on any subject related to quality assurance.
Monitor and ensure compliance on site.
Lead continuous improvement initiatives
Identify priorities of compliance requirements
Key Areas of Activity:
Product & Process Design, Development and Changes
QA Representative in projects initiated for Product and/or Process Design & Development, including both products manufactured internally & externally
Provide support to Project Leaders to build design and development plan
Participate to product & process risk assessment activities and related meetings/updates
Review all project deliverables (as per Document Matrix) and communicate with Project Leaders and QA functions regarding quality assurance activities
Provide support to Project Leaders to prepare milestone reviews
Integrated Management System
- Participate and/or generate IMS documentation:
- Work instructions
- Seek improvements in processes and search for efficiency gains in quality management systems
- Provides ongoing support to Operations, R&D, Engineering, RA & other functions regarding quality management system issues
- Participate punctuality to projects initiated, intending to introduce new tools/applications or processes
- Key player to ensure continual compliance of the quality management system with applicable requirements.
- Participate in internal, supplier and external audits & inspections (Notified Body and Authorities)
- Ensure a proactive determination of regulatory, compliance and quality issues and integrate these into audits on a priority basis.
- Conduct internal audits as Auditor/Lead Auditor, as per internal procedure and internal audit program
- Provide support on specific action intending to improve Integrated Management System.
- Provide training in this area as required
CAPA and continuous improvement
- Interface with Quality Assurance Dept, participate in investigations associated with quality issues detected at pre-market stages
- Participate in and lead cross-functional teams to identify opportunities for quality and process improvement.
Training to QA processes
- Design & develop training programs/materials for processes owned by the Dept Compliance & Validation.
- Honours Degree in an engineering or science discipline
- Experience required: 8 + years in similar role and for medical devices classified Class I, II, and III medical devices
- Certified Quality Auditor.
- Subject Matter Expert in quality management system
- High degree of organizational skills; demonstrates attention to detail
- Knowledgeable in ISO13485 and ISO14971 standards, European and US regulatory requirements
- Experience working with ISO notified body and FDA environment is expected
- Excellent written and oral communication skills
- Ability to solve complex problems, with multidisciplinary teams and various topics (product, process, organization, management)
- Oral and written communication skills
- Ability to build network within a Company, a Group or with external representatives
- Comfortable with Microsoft Office tools
- Knowledge of SAP would be beneficial
For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email email@example.com
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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