Job Description

Experienced Quality Engineer (Medical)       

Job Responsibilities

• Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained.
• Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ,OQ, & PQ), cGMP, PFMEA’s & support the generation of DMF’s were appropriate.
• Experience in automation and equipment validation.
• Leader in this field and support the necessary validation protocols, & amendments of the quality management system in ensuring compliance with the latest FDA directives/requirements within the Medical Device Sector.
• Support the external & internally Quality Management System auditing function (auditor trained).
• Exposure & involvement in implementing lean manufacturing methodologies.
• Evaluation and contribution of regulatory information to applicable documents.
• Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.

Required Experience

• Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual)
• Excellent organisation, communication, computer, & presentation skills.
• Excellent initiative, decision-making and be able to work in a core team environment.
• Solution driven with emphasis on Performance and Results.

Education/Training/Experience

• Degree in Engineering/Science (Mechanical/Electronics) discipline.
• 5 to 7 years experience in a Quality Engineering role.
• Fully competent in Quality Management Standard, with formal quality training preferable.
• Experience in a Lean environment with automated assembly is an advantage.
• Experience in a Healthcare environment is desirable.