ESSENTIAL DUTIES AND RESPONSIBILIES

• Responsible for ongoing compliance with quality and regulatory requirements
• Responsible for ISO, CE, and FDA audit preparations alongside QA RA Manager
• Support V&V processes
• Overall responsibility for document control.
• Develop quality documentation, including work instructions, inspection records, etc
• Provide in-process QA support to include inspection and document review (DHRs).
• Responsible for final inspection and product release (documentation, labeling, tests, and records)
• Track nonconforming material and lead Material Review Board (MRB) efforts
• Interface and take lead QA role in interactions with suppliers, contractors, and consultants that supply components, subassemblies, and contract processing.
• Investigate process failure and implement CAPA
• Manage aspects of internal quality system relating to receiving inspection, calibration, MRB, etc. Assist in the performance of quality system internal auditing.
• Establish, monitor, and evaluate quality system metrics.
• Provide required QMS training
• Interact with suppliers and subcontractors

QUALIFICATIONS

• Bachelor’s in Mechanical/Biomedical/Industrial Engineering or equivalent
• Previous Experience as QA engineer of least 5 years
• Proficient in English (reading and writing)
• Excellent technical understanding