Experience Requirements
Minimum of 5 years of experience in Quality Engineering, Medical Device preferred.
Qualification Requirements
Requirements Quality System Regulations knowledge (QSR 21 CFR part 820, ISO 14971, ISO 13485) Medical Device Design Control knowledge and experience (IEC/UL 60601, MDD, CMDCAS).
Preferred Qualifications
B.S. Degree, (Mechanical/ Electrical) preferred Strong skill level in engineering principles (design of experiments, statistical data analysis, tolerance analysis, risk management, human factor engineering, FMEA/FTA, reliability, validation, development and execution of protocols/reports.
Responsibilities
Work with Management and team developing/ improving programs to ensure improved quality and reliability in products, and reduce the total cost of Quality including: Reliability studies. Customer complaints. Customer returns. Field service & repairs. Represent Quality Assurance through all product design and development life cycle phases to help ensure product manufacturability, reliability and cost effectiveness. Responsible for writing and reviewing Non-Conformance Materials Review to verify discrepancy and adequacy of response to corrective action request. Create documentation associated with engineering activities including: Quality Plans. Verification & validation protocols/ reports. Update/ rewrite Quality System/ Department procedures. Participate in product complaint investigations, root-cause analysis, and corrective and preventive actions. Key contributor in Corrective Action and Preventive Action (CAPA) System. Perform Quality System/ Process Audits. Responsible for Supplier Quality system in monitoring and auditing.
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