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Quality Engineer II (Operations)

Company: Neomend, Inc
Location: irvine
Posted on: May 3, 2021

Job Description:

Job Description SummaryJob DescriptionThe Quality Engineer II (Operations) will lead activities involving product impact assessments for events, product quarantine activities, non-conformance reporting/issue resolution, auditing of production areas, and procedural updates to ensure the process and documentation is compliant with 21CFR820, ISO 13485, and other regulatory requirements as well as internal requirements.Initiates and leads QA Operations process improvements from start to implementation including creating/revising procedures using the MasterControl Change Control system.Actively participates in MRB by providing direction and support on the non-conformance process, product impact assessment, root cause analysis, and product quarantine as non-conformances arise. Ensures non-conformance reports are initiated per established requirements and applicable activities are identified and implemented.Audits personnel and processes in manufacturing areas for practice versus procedures and against current regulatory requirements (FDA, ISO, etc.). Analyze audit results for trends and provide feedback to site management.Responsible for performing Product Quarantine activities, such as entering product into quarantine, completing quarantine documentation, reviewing/disposition non-conformance records for quarantine release and removal of product from quarantine area.Leads investigations and corrective action to address out-of-tolerance calibration results, quality events, audit nonconformances, and CAPAs.Develops or assists in the development of Process Validation documentation such as protocols and reports (IQ, OQ, PQ), executes qualifications, and performs statistical analysis as required.Creates and executes component qualification protocols and reportsSupports risk management activities including review and development of process FMEAsInteract in a team environment with Operations, Quality Engineering, Regulatory, and Engineering personnel and participate in project team to help improve the process and increase product quality while keeping within compliance with site Quality Systems procedures.Lead and/or support other duties as assigned.Qualifications:B.S. Degree in Engineering, Biology, Microbiology or related field with a minimum of 3 years relevant experience or M.S. Degree in Engineering, Biology, Microbiology or related field with a minimum of 2 years relevant experience, or an equivalent combination of education and experience.Experience in Quality Engineering disciplines including product/process validation, applied statistics, and technical problem solving.Strong Compliance understanding especially in post-market activities including complaints, failure investigations, nonconforming material and CAPAs.Experience in Risk Management activities.Relevant medical device experience.Applied Knowledge of the requirements of FDA QSR, ISO 13485 and ISO 14971.ASQ certification preferred.Experience with metrology and/or calibration instrumentation preferred.Excellent problem solving and project management skills.Must have a positive attitude with excellent communication, negotiation and interpersonal skills to maintain a team oriented environment.Ability to thrive under challenging deadlines and in an energetic environment.Ability to manage multiple projects, communicate updates, and meet milestones in a timely fashion.Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.#L-PROPrimary Work LocationUSA CA - Irvine NeomendAdditional LocationsWork ShiftNA (United States of America)

Keywords: Neomend, Inc, Irvine , Quality Engineer II (Operations), Other , irvine, California

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