Quality Engineer

Job Title

Pay Range: $40.05hr - $45.05hr

Requirements/Must Have

• Bachelor's degree in engineering required.
• 2-4 years of experience required.
• Previous experience working with lab/industrial equipment required.
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Knowledge of and adherence to Quality systems.
• Good computer skills in usage of MS Office Suite.
• Ability to read and interpret drawings.
• Basic understanding of statistical techniques.

Responsibilities

• Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the organization's systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
• Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files.
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Skills

• Quality Engineering.
• CAPA.
• Non-conformances.
• Audit observations.
• Six Sigma.
• LEAN.
• Risk Management.
• MS Office Suite.
• Statistical techniques.
• Problem-solving.
• Analytical skills.
• Critical thinking.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.
• Ability to communicate effectively with stakeholders.

Qualification And Education

• Bachelor's degree in engineering.