Quality Systems Engineer
What you need to know
Do you want to work for a leading global science-based technology company in the Midlands?
Our client focuses on providing better care through patient-centred science. Helping transform patient outcomes by reducing the risk of preventable complications and restoring lives. This company has a long-standing reputation as a company committed to innovation. As a Quality Systems Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.
This is a Permanent role
Location: Athlone, Westmeath.
Your new job
Key duties & responsibilities include:
- Analyzing Quality Systems data to provide input into KPI’s, Management Review Quality Metrics Review and Post Market Surveillance Data
- Responsible user for quality management system related IT. Provide Quality Support to Software Validation for QMS.
- Independently & Analytically assess and provide guidance on quality system records.
- Implementing the CAPA Process with cross functional teams through thorough Root Cause Investigation, timely CAPA Planning and Implementation by selecting appropriate problem-solving techniques and making robust and consistent engineering and quality assurance recommendations.
- Conduct Internal Audits, Corporate Audits and Third-Party Audits as required. Quality System support for Third Party Audits both announced and unannounced as part of the audit response team to include front room and back room activities.
What are we looking for?
- Bachelor’s degree in Engineering, Science or related subject
- Lead Auditor or Internal Auditor certification an advantage.
- A minimum 5 years’ industry experience in Quality and/or Compliance within the Medical Device Industry, Pharmaceutical and / or other highly regulated Industry is required.
- Excellent organizational and project management skills, ability to effectively manage multiple projects. Attention to detail and accuracy is essential.
- Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.
- Working knowledge of applicable medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations, including MDD93/42/EEC, MDR/2017/745, SOR/98-282, 21CFR820, & 21CFR11.
- Six Sigma Green Belt Qualification
Key Benefits Include: 25 days paid annual holidays, Pension Scheme, Life Assurance Scheme, Employee Stock Purchase Plan, Financial support for further education, Subsidised Canteen (Manufacturing based)
Apply for this job now or get in touch with Aoife at email@example.com