Quality Engineer II

Job Description

• Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished products.
• Collaborate with engineering and manufacturing teams to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests.
• Perform statistical analysis to assess cost and determine responsibility for products or materials that do not meet required standards and specifications.
• Ensure corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and / or research and development as they apply to product or process quality.
• Contribute to cross-functional projects and support project milestones from design to implementation while adhering to company policies.
• Communicate with internal stakeholders to share status, needs, and issues to support decision-making.
• Provide guidance and assistance to entry-level professionals as needed.
• Other duties maybe assigned.

Requirements

Education

Bachelor’s Degree in Engineering (Required).

Experience

Minimum of 2 years of relevant experience with a bachelor’s degree, or 0 years with an advanced degree.

Demonstrated competence and practical knowledge within the quality engineering field.

Must Have

Engineering bachelor’s degree

Statistical knowledge

Statistical Process Control (SPC) knowledge

Process Validation and Computer Software Validation knowledge and experience

Nice to Have

Prior validation experience

Experience in the medical device industry