Responsibilities may include the following and other duties may be assigned. QA support for EU MDR remediation activity and ops support
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises, implements and monitors methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Participate in preparing / critically reviewing/approving NCMRs/ CAPAs/ Investigations and validation activities, providing expert QA technical direction and solutions as appropriate.
- Ensures effective product control measures in the event of issues being noted.
- Lead and support root cause driven approaches to problem solving efforts for quality issues and implements corrective & preventative actions.
- Ensures that root cause of problem & implements corrective & preventative action measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May manage some direct reports of lower levels and responsible for communication and coordination talent management initiatives with reports.
- Liases with other Client departments sites, functions and vendors on a frequent basis. Represents the site at various levels in the organisation. Makes decisions in conjunction with senior management on deadlines that impact the business unit.
- Established and productive individual contributor.
- Works independently with general supervision on larger, moderately complex projects / assignments.
- Communicates frequently with internal & external contacts.
- Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
- We are looking for a qualified person to Bachelor's Degree (Level 8) in Science/Engineering or related Discipline. Requires a minimum of 5-8 years of relevant experience