Based in the midlands, (Athlone), my clients are currently looking for a Senior Quality Engineer to join their expanding team, they are looking for someone to lead and mentor the existing Quality Engineer, move the Quality department forward with the potential of moving into a more senior manager role in time.
The ideal candidate must have a passion for quality, with a minimum of 5 years’ work experience within a medical manufacturing facility. A hands-on type that has a passion for manufacturing and quality with a career progression that shows increasing levels of quality management responsibility. An individual who can multitask and prioritise a busy work schedule while working under their own initiative and with minimal supervision.
Position Summary
Provide quality engineering support and direction in quality assurance, control and preventative activities within the operations function, with a focus on preventative measures and continuous improvement of products and processes. Ensure compliance to all regulatory and quality management standards.
Role
- Ownership of the training process for new team members.
- Ensure ongoing compliance to the QMS system for the manufacturing site.
- Work closely with our suppliers and business partners to develop mutually beneficial relationships.
- Work with operations to ensure quality performance of product and processes.
- Collaborate with global RA/QA, customer and supplier teams to address top quality issues and partake in regulatory audit processes.
- Ownership of internal and supplier non-conformances and the timely closure of NC’s
- Ownership of CAPA, root cause investigation, implementation, and timely closure.
- Ownership of the product disposition process.
- Engage in the development and improvement of internal manufacturing processes for existing products.
- Participate and lead in the creation and/or review of new or modified work instructions and procedures.
- Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
- Partake in regulatory audits and be the site representative where required for same.
Qualifications required
BS in a science, engineering, or related discipline.
Lead auditor certification to ISO 13485
Minimum of 5 years’ experience.
For more information, please contact me at annemarie@amfconsulting.ie or 0879728431