As a Quality Engineer, you will provide support in quality assurance, control, and manufacturing activities with a focus on continuous improvement of products and processes for in-house developed technology. You will support the execution of initiatives and projects to enhance quality performance within the business, ensuring compliance to regulation and standards.
- Support supplier quality activities impacting daily operations.
- Work closely with R&D and Manufacturing to execute product and process verification and validation activities in accordance with quality system policies and practices.
- Execute quality risk management including hazard/failure mode effects analysis.
- Develop appropriate product inspection and process monitoring criteria and methods.
- Execute and track Design Control activities.
- Own and manage internal and supplier driven non-conformances and CAPAs, ensuring timely containment actions, corrections, root cause investigation, implementation of corrective actions, and closure.
- Monitor KPIs for monitoring of process and/or product quality, perform analysis and interpret trends.
Responsibilities
- Critical attributes include creativity, initiative, a hands-on approach and multitasking.
- Excellent analytical abilities coupled with strong written and verbal communication skills.
- Good at determining the processes necessary to get things done; can simplify complex processes.
- Ability to establish, build and maintain positive working relationships.
- Excellent interpersonal, verbal and written communication skills.
- Effective communication and writing skills
Qualifications
- Degree in Engineering or Science discipline.
- Minimum of 2 years’ quality related experience in the medical device industry
For more information, please call me on 087 9728431