Description
- Participates as a cross-functional team member in new product development team activities, representing the interests and concerns of the quality assurance/quality engineering function
- Applies knowledge of FDA Quality Systems Regulations and International regulations, specifically related to Class II and III medical device design control areas, in carrying out responsibilities. Areas of responsibility include review and approval of verification and validation processes for products that may contain implantable medical devices and/or electrical equipment.
- Develops and maintains risk management files include the generation or participation in Failure Mode Effects Analysis or Fault Tree Analysis, determination of risk hazards, and construction of risk reports.
- Develops, implements, and maintains cost-effective Quality System procedures consistent with corporate, government and international regulations.
- Leads quality improvement projects that benefit the inspection, testing, assembly, or development of products.
- Keeps abreast of changes to domestic and international regulations, standards, and guidance documents.
- Identifies and drives continuous quality improvement in area of responsibility.
- Understands and is able to review quality records to verify information is correct and complete and that specifications have been met.
- Conducts failure investigation to analyze internal system or process failures and implement preventive and corrective action. Uses various statistical and non-statistical problem-solving tools as part of analysis.
- Assists in the training of Quality Assurance, Development, and/or Production employees in Quality System related procedures or improvement programs.
- Under general supervision, designs and implements methods and procedures for testing and inspecting the quality level of products and production equipment. Reviews supporting manufacturing documentation to ensure it contain the necessary criteria and provisions to permit effective inspection and testing of materials.
Minimum Qualifications:
- BS degree in engineering discipline (Mechanical, Electrical, or Bio-Mechanical preferred).
- Minimum of 2-5 years' experience in quality assurance / quality systems.
- Working knowledge of the FDA medical device Quality Systems Regulations and international quality system standards is required.
To find out more about Real please visit www.realstaffing.com