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Validation / Process Engineer - Healthcare Technology

Company: Raland Compliance Partners
Location: Vista
Posted on: November 23, 2021

Job Description:

Our healthcare technology client is a pioneer in healthcare diagnostics. They develop and manufacture portable, compact medical diagnostic products that help people, organizations, and communities protect human health. If you would like to work in an extremely collaborative environment with an innovative team and you are passionate about healthcare, then this six-month contract engagement might be just the right opportunity for you.Validation / Process EngineerThe Validation / Process Engineer will provide technical expertise for the manufacturing and quality organization concentrating on the validation of complex automated manufacturing systems. The position will require interfacing with all functions (Information Technology, Quality Assurance, Operations, Engineering, and R&D.)Responsibilities: Work with quality teams, and other functions to create and/or modify methods and procedures to ensure appropriate validation activities are conductedCollaborates across functions, leveraging others' quality and technical expertise to identify key process and product parameters to be validatedProvide quality support to the process verification and validation effort including all required validation activitiesDevelopment and documentation of full suite of validation deliverablesSupport supplier selection, audit, and management as requestedSupport product failure investigations and required corrective / preventive actionsAdditional duties as assignedRequirements: BS / BA in an engineering, technical field5+ years quality engineering experience in the product development, manufacture, and validation of medical devices or IVDD productsKnowledgeable of Quality system principles; FDA Quality System Regulation (cGMP); IVDD 98/79/EC, IEC61010, ISO 13485 quality system standards. Knowledge on MDSAP and IVDR is a plusExperience in product development in a regulated environment, including design control, hazard analysis, validation, and process metricsKnowledge of ISO14971 Risk Management Systems requiredAbility to work with development engineers and other functional group personnel to accomplish common goalsSelf-disciplined able to work under minimum supervision in fast paced environmentDetail oriented, with good written and verbal English communication skillsComputer literate in word processing, spreadsheets, databases, and other quality related productivity programsCQE/ASQ Certification is a plusBe flexible on work schedule. Be able to work during weekends or evenings when required.Travel between client sites in Southern CA requiredLength of Engagement: 6 monthsPlease note: We are NOT offering sponsorship at this timeThis is NOT a corp to corp opportunityJob Types: Full-time, ContractPay: $55.00 - $75.00 per hourSchedule:8 hour shiftDay shiftMonday to FridayAbility to commute/relocate:Vista, CA 92081: Reliably commute or planning to relocate before starting work (Preferred)Education:Bachelor's (Preferred)Experience:validation: 5 years (Preferred)CGMP: 5 years (Preferred)ISO 13485: 5 years (Preferred)ISO14971: 2 years (Preferred)IVDD98/79/EC: 2 years (Preferred)License/Certification:Certified Quality Engineer (Preferred)Willingness to travel:25% (Preferred)Work Location: One location

Keywords: Raland Compliance Partners, Vista , Validation / Process Engineer - Healthcare Technology, Healthcare , Vista, California

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