Quality Assurance Specialist
7 days ago
The Quality Assurance Specialist will be responsible for ensuring the successful functioning of our manufacturing facility by supporting all quality aspects.
- Qualifications and Experience:
- A third-level qualification in engineering, polymer science, or equivalent manufacturing experience is required.
- Experience in statistical analysis (Minitab), SPC, and validations is essential.
- Excellent interpersonal, communication, influencing, and facilitation skills are necessary.
- A minimum of 3 years' experience as a Quality Assurance Engineer within an injection moulding or medical manufacturing environment is required.
Duties and Responsibilities:
- Sustain and Improve QMS: Develop and implement solutions to sustain and improve the QMS.
- Compliance: Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
- Customer Interface: Interface with customers on new products, quality issues, and process qualifications.
- Process Control: Develop and implement process control programs to ensure customer requirements are met.
- Process Validations: Carry out process validations and qualification on products.
- Manufacturing Support: Provide manufacturing support and quality expertise in relation to manufacturing issues and product disposition.
- Quality Engineering Analysis: Perform quality engineering analysis to identify strategies to prevent quality non-conformances and minimize risk.
- NCR/CAPA Process: Coordinate NCR/CAPA process to ensure timely resolution and closure of issues.
- Training: Lead training activities on quality procedures, e.g., compliance, GMP, audit prep, and GDP.
- Site Representation: Support and represent the site during external audits and carry out internal audits.
- Quality Data Analysis: Trend and track quality data to support quality improvements across the business.
- EHS Requirements: Support environmental, health, and safety requirements, training, and regulations.
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