REQUIREMENTS:

• Minimum bachelor’s degree in science, engineering, or related field or equivalent.
• Minimum of two (2) years in a medical device or supplier organisation.
• Experience working in both an FDA and European regulatory environment is preferred.
• Experience with medical device regulations including GMP (Good Manufacturing Practices)
• FDA QSR (Quality Systems Regulations), and ISO quality requirements, is preferred.
• Strong initiative and follow through in executing responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
• Excellent problem-solving, decision-making, and root cause analysis skills are desired (DMAIC).
• Knowledge and demonstrated practice of risk management methodologies as per ISO 14971.
• Experience in Ethylene Oxide sterilization, Gamma Sterilization, biocompatibility, and transportation testing is an advantage, though not required.
• Prior audits or inspections experience is an advantage.
  For more information and a confidential discussion on the role, please contact me on 091 706717

THE ROLE:

As Quality Engineer I, you will get the opportunity to apply your engineering knowledge in areas such as quality systems, supplier controls, design assurance, test method development and validation, design controls, and regulatory affairs.

RESPONSIBILITIES:

• Apply quality engineering expertise in various areas throughout the Quality Management
• System.
• Support the development and certification to ISO 13485 and 21 CFR Part 820.
• Support Design & Development activities, including design controls, verification and validation.
• Support the development and validation of test methods to access the performance and quality of medical devices.
• Support the development and validation of computer system validation / assurance programs to meet regulatory requirements.
• Collaborate with all relevant departments to support quality policy and quality objectives.
• Support risk management activities and usability engineering.
• Support document control activities through QT9, including performance of administrative duties of QT9 (eQMS).
• Demonstrate strong initiative follow-through, and effective project leadership in execution responsibilities, overcoming obstacles, and managing multiple priorities.
• Drive CAPA and NC management and investigation to effective and timely resolution.
• Support the Internal and External Auditing Program and resolution of any actions arising.
• Support the identification updates to relevant Standards and Guidance, including appropriate GAP assessments to support product development certification.
• Perform an integral role in Supplier Quality Management activities, including maintenance of supplier selection and evaluation, maintenance of Approved Vendor Listing and associated documentation.
• Other duties as required to support business goals and key performance indicators.
• As a Quality Engineer I you will get the opportunity to apply your engineering knowledge in all areas of the Quality Management System that will support the business as we bring our products to market.