ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485
- FDA QSR
- ISO 14000
- Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
- Trend analysis of data from the controls
- Potential improvements for review with engineering based on the trends.
- Areas for Improvement to senior management.
- Review and propose changes to sampling plans based on trend analysis and changes to the system.
- Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements.
- Support the Complaint/CAPA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
- Execution of Quality Validations and preparation of associated documentation as required.
- Review, update and approve Quality procedures as required through ECO process.
- Action NCR and CAPA in an appropriate and timely manner.
- Raise appropriate Variation Permits as required, in line with customer and regulatory requirements.
- Support Customer and Regulatory Audits.
- Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner.
- Engineering Change Order (ECO).
- Complaint/Corrective and Preventative Action (CAPA).
- Material Review Request (MRR).
- Internal Audits.
- Failure Mode Effect Analysis (FMEA).
- Variation Permits (VP).
- Project meeting attendance and provision of quality support as required.
- Attend and participate in daily cell meetings.
- Preparation of information for KPI and Management Review meetings.
SKILLS AND KNOWLEDGE:
- Ability to communicate and work with people inside and outside the department.
- Good communicator (written and oral).
- Ability to train and lead where required.
- Ability to co-ordinate, plan and organise in a timely manner.
- Knowledge of engineering theories and methods.
- Good technical report writing skills.
- Rigorous attention to detail.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
- Engineering or science Degree preferably with Quality Engineering included.
- Quality Department or similar experience in regulated industry.