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Senior Quality Engineer

Company: Aerotek
Location: Santa Rosa
Posted on: April 9, 2021

Job Description:

The position of Quality Specialist, Consultant is within our Toxicology business unit located in Santa Rosa, CA . This job description will be reviewed periodically and is subject to change by management.RESPONSIBILITIES: Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervisionAbility to interact effectively with all levels of the organization and perform multiple tasks in a fast-paced environmentWorks on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations.Knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485, CMDR, etc.Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activitiesResponsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices; build productive internal/external working relationshipsCarries out duties in compliance with established business policiesOther duties as assigned, according to the changing needs of the businessIn addition, the role supports other elements of the quality management system e.g: Document control system (Agile); Develop, implement and maintain laboratory quality processes and procedures, in compliance with applicable laboratory regulations and ARDx policies.Implement a robust nonconformance (NC) and CAPA program, including leading root cause investigations, supporting development of action plans, ensuring comprehensive documentation of NC/CAPAs. Regularly report on quality and regulatory performance, including trending and analysis of deviations and non-conformance, to inform laboratory quality objectives, priorities, and improvements.Report on monthly, quarterly and other periodic reports.Skills:Quality assurance, Quality engineering, Root cause analysis, CAPA, Agile, Document Control, QSR, ISO 13485, CMDR, in vitro diagnostics, Quality System Regulations, MS office, Medical Device Manufacturing, AuditTop Skills Details:Quality Assurance, Quality System Regulations, CAPAAdditional Skills & Qualifications:Bachelor's DegreeMinimum of 10 years of related experience Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnosticKnowledge of Quality System RegulationsExperience with MS Office Able to work on multiple tasks as a team member and/or ability to operate as an individual contributorMust be detail-orientated, self-motivated and available for flexible schedulingStrong communication, problem solving and motivational skillsCOMPETENCIES:High level of attention to detail TeamworkCommunicationStrong organizational skillsInitiativeAdaptability-someone who can lead multiple projects from start to finish-self starter 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, Santa Rosa , Senior Quality Engineer, Other , Santa Rosa, California

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