PharmaLex is hiring a
Quality Engineer, United States

Summary

The job is for a Technical Specialist at PharmaLex, a growing consulting company in the Healthcare industry. The role involves developing quality standards, collaborating with engineering and manufacturing functions, inspecting, testing, and evaluating products, and designing inspection and testing mechanisms. The candidate should have a BS Engineering degree, preferably in Software, Mech, or Chem Engineering.

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
• Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
• May act as a mentor to colleagues or may direct the work of other lower level professionals
• BS Engineering (Software, Mech and Chem Engineering preferred)

Responsibilities

• 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

Preferred Qualifications

• Experience reviewing and approving validation test plans, reports, and deviations
• Capable of performing statistical analysis to support validations and product release
• Knowledgeable of medical devices manufacturing regulations