Sr. Quality Engineer - Diverse Linx

Job Title: Sr. Quality Engineer

Location: Memphis, TN - Onsite

Duration: Full Time-Only

Job Description:

Experience Required

• Design verification and validation work Risk management Testing protocols and reports Design history file remediation Complaint investigations Complaint trending and coding Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies.
• Detailed knowledge of FDA, GMP, ISO 13485, and ISO19471, 21CFR PART 11 & 21CFR PART 820.
• Bachelor s Degree in engineering or Technical Field or equivalent combination of education and work experience Min 5 years of related experience

Roles & Responsibilities

• Develops quality standards and protocol for processing materials into partially finished or finished materials product. Creating Procedures for inspecting/ testing Designs or specifies inspection and testing mechanisms and equipment. Conducts quality assurance tests Performs statistical analysis 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 PFMEA, Process controls, MSA, Supplier Validation (IQ/OQ/PQ), Process Capability 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.