SR Quality Engineer
SR Design Quality Engineer
• Actively participate in design reviews and give feedback on design inputs and outputs ensuring that the designs comply with regulations
• Works with Product Development on design Verification and Validation activities.
• Reviews and approves all Product Development Design Testing protocols and technical reports.
• Works closely with Regulatory Affairs to ensure that Technical Documentation conforms to appropriate standards, for 510k submissions, Technical Files and ROW.
• Will make the final decision for release. Works closely with the Sterilization Group and reviews new designs for adoption into the current sterilization validations.
• Works with Product Development and Materials Management for new supplier selection and approval. Documents Supplier risk assessments to ensure that the supplier will be able to provide a safe and effective device.
• Works with Product Development to identify device critical features and Control Plans for new products.
• B.S. in engineering or related engineering field.
• Minimum of Five (5) years of quality, regulatory or product development experience in medical devices. Minimum of Two (2) years hands on experience performing risk assessments to ISO 14971.
• Ability to travel approximately 5%.
• Strong background in quality and regulatory compliance.
• REQUIRES A THOROUGH KNOWLEDGE OF: The Food and Drug Administration’s CFR 21 Part 820; Risk Management systems such as ISO 14971 Risk Management – Application of Risk Management to Medical Devices; International Quality System Regulations such as: ISO 13485, Medical Device Directive 93/42/EEC, Canadian Medical Device Regulations SOR/98-282, Brazil’s GMP Requirements for Medical Devices and IVDs, Australia’s Therapeutic Goods (Medical Devices) Regulations, South Korea’s Medical Devices Act and any other relevant international regulation as they relate to design, risk management and clinical evaluation.