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Design Quality Engineer Jobs

Newbury Park, California

<p> Company Overview: Creating value by bringing together the right people to achieve results is our motto. Our clients and employees say they choose to work with us because of how we work with them – with service that exceeds their expectations and a personal commitment to their success.</p><p> About CLIENT: Our client is an American multinational biopharmaceutical company, seeks an accomplished Design Quality Engineer ******************************************************************************************************************* Position: Design Quality Engineer Location: Thousand Oaks CA 91320 Duration: upto 24 months with possible extension</p><p> Pay Rate: $45/hr – $56/hr (depending on experience)</p><p> Relocation Expenses/ Assistance: NO</p><p> Job Description: As a member of Commercial Quality group for drug delivery systems, this position will provide Quality engineering support for new product development and ensure design control systems are followed in the creation of new drug delivery devices. Responsibilities include participation in Design development, Design control per FDA CFR 820.30, Corrective and Preventive action projects; responsible for documentation related to investigation of product complaints, trending of quality data, and other assignments as given. With general guidance, employee will work with process development and operations to ensure robust designs are verified, validated, qualified and launched. In addition to new development the responsibilities will include working on cross functional teams to understand product inquiries, reduce complaint rates and provide support for troubleshooting operational issues and capital projects. Employee will develop, organize, analyze, present and implement results for operational issues or engineering projects of moderate scope and complexity.</p><p> Job Requirement: BA/BS in Science, Engineering, or related field Experience with Quality systems should include: ISO 13485 or FDA CFR 820.30 related compliance regulations and management of engineering development procedures. 10+ years of Quality or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in validation, investigations and/or change control</p><p> Preferred Qualifications Knowledge of Design Controls Experience with product design enhancements/improvements Experience in interacting with regulatory agencies Good written and verbal communication skills Ability to interpret and apply regulatory and quality requirements Ability to work independently as well as on teams Ability to prioritize and manage multiple tasks Ability to work in a challenging and fast-paced work environment</p><p> Top 3 Must Have Skill Sets: Understanding of design controls Understanding of CAPA/NC and relevant procedures Quality engineer be able to work with minimal oversight, critical thinking ******************************************************************************************************************* I’d love to talk to you if you think this position is right up your alley, and assure a prompt communication, whichever direction.</p><p> If you’re looking for rewarding employment and a company that puts its employees first, we’d like to work with you.</p><p> Sajag Bhardwaj Recruiter ******************************************************************************************************************* NOTE: Candidates that are offered a position are required to pass pre-employment drug and background screening.</p>

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