Quality Assurance Manager

Contract Quality Assurance Engineer

Must have ISO 13485 experience and be Lead Audit Trained

Description:

Responsible for supporting process owners in defining and implementing processes and system changes analyzing process improvements to drive efficiencies. Support the local quality management system and processes. Is an advocate of Quality and promotes the group's vision and mission while supporting the goals of the overall business.

Responsibilities:

• Work on compliance project / objective activities to completion.
• Prepare monthly metrics for their area of expertise / responsibility.
• Analyse process data, trends and drives optimization / improvement.
• Represent QA organization in specific processes (e.g. CAPA, Order fulfilment, Manufacturing, etc.)
• Support others in the QA organization and other functional organizations on technical aspects in order to drive results.
• Participate in the execution of the internal audit plan.

Required skills and experience:

• Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO13485, ISO14971, ISO 63304, IEC, MDR, QSR, CMDR.)
• Proven experience in relevant areas of Quality, Regulatory, Software Engineering or Engineering, preferably within a medical device environment.
• Strong written and verbal communication skills and ability to collaborate effectively.
• 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.
• Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
• Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
• Ability to work efficiently under tight timelines.
• Proven fluency in English and other applicable languages relevant to their specific geographies.
• Quality professional certifications preferred (e.g. CQI, CQMoE, CQA, CQE.)
• Experience in quality improvement tools and techniques is a plus (e.g. Lean, Six Sigma, DOE, Statistical Methods, etc.)

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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