We have 10 fantastic new opportunities to work in our Quality Assurance department. The successful candidates will be involved in:
- Ensuring that the quality management system in manufacturing meets all requirements of all relevant regulatory standards and Regulations : ( ISO9001/13485, FDA CFR 820 part 21 , QSR's)
- Working within the QA team located in manufacturing to ensure the company maintains compliance to external and internal quality system requirements.
- Working alongside manufacturing teams and advise on quality related issues/ day to day issues. Quality Engineer in manufacturing is responsible for assuring that manufacturing processes are in compliance with ISO/cGMP Quality Management System to produce consistent quality product.
- Reporting to the Quality Engineering Manager, The Quality Engineer is also responsible for identifying opportunities and supporting improvement and reduced variation in our manufacturing processes resulting in improved metrics such as Overall Equipment Effectiveness (OEE), Scrap reduction and ability to leverage increased quality for delivery performance improvements, etc.
Principal Duties and Responsibilities.
To provide quality support to the day to day functions within their manufacturing department, including;
- To be responsible for ensuring that all quality issues, and audit non-conformances are dealt with efficiently and promptly.
- Manufacturing to own process - and raise NCR
- Quality Engineers are responsible for ensuring that appropriate NCR/CAPA investigations are carried out in conjunction with manufacturing , and root cause analysis within the manufacturing department arising from recurring non-conformances, audit non-conformances, and other investigations using problem solving tools to identify root cause and implement effective corrections / corrective actions
- Quality engineers will be responsible for the disposition of NCR
- Responsible for quality monitoring within the designated manufacturing department.
- Review non-conformance and other manufacturing metrics to identify CAPA opportunities
- Analyse and review process capability data and other quality metrics in order to propose specification or process changes to manufacturing processes Research, recommend and implement new and improved gauging, measurement and data acquisition systems to improve inspection efficiency and repeatability and reproducibility of measurement systems
- Updating documentation where required using the standard format templates, ensuring documents are updated in a timely manner
- To contribute to the development of policies, procedures, specifications and protocols within the department.
- Responsible for ensuring SOP management within the department.
Process validation / Equipment
- Determine need for validation of new or changes to, equipment or processes designated manufacturing department
- Work with Engineering on validation protocol development, documentation, and approval (IQ, OQ, PQ) to ensure effectiveness
- Responsible for the documentation and process management in validation- IQ, OQ, PQ close-out review, justification, and approval.
- Responsible for ensuring validation of process/equipment is up to date.
Quality representative on Process Changes / Projects
- Facilitate with the Change management process supporting manufacturing
- Use risk management tools (PFMEA) to evaluate impact of change.Ensure product verification and processvalidation requirements are reviewed and defined appropriately.
- A level or equivalent
- Working knowledge of FDA part 820, ISO 13485
- Experience of working within QA Engineering or manufacturing QA position in a manufacturing environment within the IVD or Medical Device Industry/ or regulatory industry
- Strong communication skills both written and verbal.
- Good understanding for Quality principles / Quality systems.
- Experience of non-conforming product and corrective action processes.
- The ability to problem solve.
Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and
- Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
Leadership Skills: Proven ability to influence others and lead significant change.
- Able to work with minimum supervision and as part of a team.
Strong communication skills
- Degree or equivalent in Biological sciences or similar
- Quality Assurance/ manufacturing engineering background
- Currently working in a similar role.
- Quality Assurance
- Quality Engineer