Quality Engineer

Job description

JOB DESCRIPTION:

Position Summary:

Works closely with development/manufacturing to establish/ensure compliance with the quality system. Works closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. He/she establishes/monitors quality assurance efforts to ensure that the company's products conform to quality standards. Works with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes.

Essential Functions:

• Provides Quality Engineering Body of Knowledge support to company and organization.
• Verify company's adherence to the established Quality System and GMP/ISO standards.
• Work with Engineering, Manufacturing, Laboratories and Regulatory to establish measurable, valid product requirements.
• Aide in definition of test equipment as required accomplishing quality responsibilities.
• Develops and documents test plan protocols, test procedures, and test reports, typically with mentorship from higher level engineering.
• Perform tests according to various protocol requirements.
• Assist in completion of risk management and risk analysis including FMEA.
• Assist in completion of customer complaint related investigations.
• Work with R&D on device design verification and design validation plans for products based on performance specifications and risk analysis.
• Analyze and communicate conformance to specifications and standards.
• Conducts technical and statistical investigations concerning optimization and compliance to specification.
• Assist in measuring process capability, process controls, and process validation. Assist in definition of CTQ parameters.
• Aide in definition of sampling plans and inspection methods.
• Assist in specifications and testing of sterilization methods.
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
• Perform other duties and responsibilities as assigned by senior management.

Qualifications:

• Bachelor Degree required in Engineering, Technical Field, or Business Administration.
• 5 years experience in Quality Engineering positions.
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
• At least 3 years of experience in Quality or Manufacturing Engineering positions.
• Knowledge of statistical/data analysis and reporting.
• Strong documentation and writing skills.
• Experience on Quality tools/methodologies.
• Knowledge of FDA, GMP, and ISO 13485.
• Experience in process improvement tools such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
• Knowledge on product and process qualification and validation.
• Experience with control of nonconforming material, corrective and preventive actions.
• Intermediate to advance command of English required.

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