
Senior Quality Assurance Specialist
4 days ago
A leading manufacturer is currently seeking a committed and driven validation engineer to join their team.
Company Overview:The company has a proven track record in producing high-quality products and is committed to world-class product design expertise, manufacturing excellence, and a strong strategic global footprint.
This is a fantastic time to be joining the company as they are going through a period of high growth and are expanding their production facility to meet the demand for their products.
Key Responsibilities:- Write and execute process validation protocols and report for new product introductions and revalidation due to process/material improvements
- Involved with the maintenance and support of compliance to ISO 13485 and ISO 14001 systems standards
- Incorporate solutions to sustain and improve the QMS
- Strong focus on continuous improvements through Lean Six Sigma methodologies
- Direct support and involvement in GMP and regulatory Audits
- Review and execution of Factory acceptance testing and site acceptance protocols
- Prepare and deliver training modules as required
- Third level qualification in an engineering discipline or Polymer science
- 3 to 5 years' experience as a Validation Engineer in a injection moulding/medical device background
- Experience in statistical analysis (Minitab)/ SPC/ Validations is a must
- Possess the ability to be influential and proactive in their approach to there day to day duties
- Strong attention to detail and possess a hardworking competency
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