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Quality Engineer

Company: Aerotek
Location: Allentown
Posted on: April 9, 2021

Job Description:

Description:MUST HAVEStrong root cause analysis experienceTechnical Writing experienceInvestigations experienceCAPAsAbility to generate sampling plans-Establishes quality standards for products and processes and suggest modifications meant to prevent defects in components or final products.-Works closely with cross-functional teams, including product design, product management and production, to identify and mitigate quality risks.-Audits production processes, raw materials or suppliers/vendors to ensure that established quality standards are met.-Conducts root cause analysis for defects, non-conformities or other quality failures.-May be responsible for ensuring compliance with formal external quality standards, such as ISO 9001.- Focus will be on Data Integrity investigations; including review of CGMP data or documentation, conducting root cause interviews with personnel, leading root cause investigations, compiling nonconformance reports, and monitoring remediation actions. - Conducts CGMP Data Integrity Risk Assessment, identifies and analyzes risks, and establishes remediation plans. - Make Quality decisions based on factual information.Skills:Quality Engineer, technical writing, investigations, sampling plans, corrective action plans, Root cause analysisTop Skills Details:Quality EngineerRoot Cause AnalysisTechnical WritingInvestigationsSampling PlansCorrective Action PlansCAPAAdditional Skills & Qualifications:Bachelor's degree required1-4 years experienceIn depth knowledge of FDA guideline 21 CFR Part 820 compliance requirements and ISO9001 & ISO13485 standards. Knowledge of Data Integrity Requirements based on FDA guidelines.Excellent written and verbal communication skills with demonstrated ability to work cross-functionally across different functional groups and demonstrated ability to prioritize and manage multiple tasks and projects effectively and efficiently.Knowledge of acceptance sampling techniques and applications.Experience with Risk Management Tools and Process Mapping.Experience Level:Intermediate Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Allentown , Quality Engineer, Other , Allentown, Pennsylvania

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