Senior Quality Engineer - Regulatory
📋 Role Overview & Responsibilities
Top 3 Must Have Skill Sets: • Demonstrated strong communication and technical writing skills with cross functional groups, (QA, MFG., Leadership)• Direct experience with regulated environments (FDA, OSHA) with an emphasis in promoting safety and quality in their area of work.• Bachelor's degree in engineering or another science-related field with 5+ years of relevant work experience in operations/manufacturing environment
Day to Day Responsibilities: The Engineer role will provide direct engineering technical support as follows:• Be individually accountable for deliverables on key capital projects. This may include rationale development for improvements and identification of design requirement. In addition, translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.• Providing problem solving support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action• Lead in the identification of critical quality parameters and process attributes for new equipment or facility modifications.• Oversee and assist with development and execution of validation protocols in line with CQP and cGMP standards.• Lead, evaluate, and manage performance of contract resources.• Provide oversight for verification deliverables developed by outsourced/contract verification staff.• Act as a liaison between Engineering, Manufacturing, and Quality Assurance during project planning, execution, and closeout.• Lead and assist other engineers with troubleshooting, maintenance, and project management.• Ensure safety during commissioning, validation, maintenance, and manufacturing activities.• Review and approve the commissioning report and ensure that all validation exceptions have been adequately addressed.• Conduct and document periodic equipment validation reviews.• Provide ad hoc technical support and guidance for manufacturing and maintenance• Perform equipment troubleshooting and root cause investigations using LEAN tools (Fishbone, 5-Why, etc.)• Participate in internal audits and assess risks in conjunction with QA.• Develop and maintaining metrics related to equipment performance• Triage and Own Deviations as well as lead team on quality based decisions.
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This position is located in Thousand Oaks, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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