Quality engineer

Descripción general

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 to devise 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 proces

Requisitos para aplicar

• Bachelor level degree in Engineering
• 3-5+ years of experience.
• Previous Quality Engineering experience.
• Solid communication and interpersonal skills.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Advanced English level and solid writing skills (preferred).
• Prior medical device experience (preferred).
• ASQ CQE certification (preferred).
• Knowledge and experience with process validation, control of nonconforming material, corrective and preventive actions (preferred).
• Project management skills and demonstrated experience (preferred).