Quality Engineer II

About the role

As an operations quality engineer, this role supports production of Class III pharma products by working with cross functional teams in resolving technical issues through NCMR and/or CAPA, making process improvements, updating work instructions, and by supporting operators, inspectors, and technicians every day for making and inspecting components, sub-assemblies, and finished goods.

Responsibilities

Responsibilities may include the following and other duties may be assigned.

• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Qualifications

• Bachelor's degree in engineering field.
• Minimum 2 years' experience in a Class II or above medical device company.

Skills & knowledge

• NCMR & CAPA
• Gage R&R, Test Method Validation, IQ/OQ/PQ
• Root Cause Analysis, 5Whys, Fishbone, Cause and Effect analysis