Quality Engineer
As a Quality Engineer, you will support the local quality management system and processes. You will act as an advocate of Quality and promotes the group's vision and mission while supporting the goals of the overall business. You will work closely with functional teams in areas such as, Supplier Quality, Manufacturing ,Order fulfilment, and Regulatory Affairs, among others.
Responsibilities
Work on projects / compliance activities to completion.
Prepare monthly metrics for their area of expertise / responsibility.
Analyze process data and trends and drives optimization / improvement.
Represent QA organization in specific processes (e.g. CAPA, Order fulfillment, Manufacturing, Deviation management etc.)
Support others in the QA organization and other functional organizations on technical aspects to drive results.
Participate in external audits before regulatory authorities.
Promote and maintain adherence to company values.
Preparation of Internal audit plans, execution of audits and preparation of audit reports as applicable.Required skills and experience
Bachelor's degree in engineering or equivalent or a related field or a formal engineering apprenticeship with demonstrated experience in a similar role
Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO, IEC, MDR, MDSAP.)
Lead audit trained in ISO13485/9001
Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment.
Strong written and verbal communication skills and ability to collaborate effectively as part of a team.
Objective driven and customer focused.
Capable of producing results working unsupervised under own initiative.
Professional integrity. Able to translate regulations into meaningful business requirements.
Possess a structured approach to problem solving with an appreciation of quality tools & techniques.Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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