Quality Engineer - Full-time / Part-time

Quality Engineer

• Develops technical specifications for materials, intermediates and finished products. With Global Product Development and Contract Manufacturing staff, develop, review and approve designated raw material, formulation, intermediate and product specifications. Serves as independent quality reviewer or approver for controlled documents and reports as needed.
• Assists in the development of test plans and process validation protocols. Provides input for sampling plans, test methods, and acceptance criteria. Reviews and approves test plans, protocols, and reports.
• Develops systems for data and statistical analysis. Serves as the subject matter expert on design of experiments and statistical analysis in support of materials, processes, and products.
• Interfaces with plant engineering, operations and quality to ensure technology transfer for new products is performed in accordance with regulatory and manufacturing site requirements. Develops and implements at line sampling plans and testing/inspection methods.
• Analyzes data (complaints, material nonconformances, and waste) for trends and product quality continual improvement opportunities.
• Advocates and teaches advanced quality tools such as DoE, multivariate analysis, and root cause analysis.
• Serves as the back up to the Quality Engineering Manager during FDA/regulatory inspections of the Technical Center.
• Other duties may be assigned.

Required Skills

• Bachelor's degree in science or engineering will be required.
• For Level II: 3-5 years Quality Engineering or Quality Assurance experience in an FDA regulated industry, preferably drugs or medical devices. Additional experience working in a technical and/or scientific function desired. For Level III: Subject matter expert with 5+ years Quality Engineering or Quality Assurance experience in an FDA regulated industry, preferably drugs or medical devices. Additional experience working in a technical and/or scientific function desired.
• ASQ technical certification (CQE, CSSBB, CSSGB) highly desired. Must have strong statistical application background and experice using statistical software packages (e.g., Minitab, JMP, Infinity QS).
• Prior experience in validation of processes for OTC drugs and class I medical devices, is preferred
• Excellent analytical skills and strong communication skills.
• Ability and willingness to travel up to 20% per year, both domestic and international.
• Computer proficiency, in Microsoft Excel, Word, Windows NT, and statistical software

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 844 895-8598 or email . However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.