Quality Assurance Engineer

Company: KDL Consultants Ltd
Location: Santa Rosa
Posted on: March 24, 2020

Job Description:

NO SPONSORSHIP - - - -MUST BE ELIGIBLE TO WORK IN USA WITHOUT SPONSORSHIP Essential - MINIMUM 2 YEARS EXPERIENCE IN EITHER a Clinical Laboratory Or Medical Devices or Biotechnology environment Description We have an exciting opportunity for a Quality Assurance Engineer -within a Laboratory for our Global Medical Device Manufacturing client who are specialists in POC Diagnostics - -This role is responsible for oversight of technical quality assurance primarily focused on ensuring that all aspects including facility, equipment test methods, processes and software and subsequent changes to them, are validated in compliance with applicable regulations and standards. This role works closely with all departments especially laboratory operations and IT teams to develop and maintain the site"s validation status. This position will play an important role in coordination of validation projects including QMS optimization. The Quality Engineer will work with the site on non-conformance and CAPA investigations and is expected to perform their duties with a high degree of independence, reporting to quality and site leadership on status of validation program and risks. RESPONSIBILITIES Oversee and manage laboratory validation master plan and maintaining the facility in a validated state. Collaborate with peers to draft, review and approve validation protocols and reports. Provide guidance/training on the use of appropriate statistical techniques and sampling plans with respect to the laboratory and other validations, nonconformance and CAPA programs and other testing protocols. Lead teams in root cause analysis of laboratory quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.) and work with peers to develop corrective action plans. Assist in process data collection and analysis to monitor performance of key laboratory processes. Support the NC and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to closure. Support internal and external audits/inspections as necessary. Represent the Business unit in Validation Communities of practice. Perform other duties & projects as assigned. Carry out duties in compliance with established business policies. BASIC QUALIFICATIONS Bachelor"s Degree or equivalent in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experience. Minimum 2 years" experience in regulated environment such as laboratory or medical devices or Biotechnology. Experience with root cause analysis, failure mode analysis. Previous experience contributing to or managing validation projects from the point of inception to completion, including those that require multiple skills. Full time, permanent Position

Keywords: KDL Consultants Ltd, Santa Rosa , Quality Assurance Engineer, Engineering , Santa Rosa, California