Quality Assurance Expert (Hybrid)

Ivoclar Vivadent Manufacturing Inc • Somerset, NJ • 3h ago

Quality Assurance Expert Location: Somerset, NJ (Hybrid) Position Responsibilities: Assist the Director of QA/RA in maintaining Quality Systems policies and procedures to ensure regulatory compliance by following FDA QSR, MDD, MDSAP, ISO and any other regulatory requirements as assigned.Identify, prioritize and drive continuous improvement opportunities for QA systems. Lead projects aimed to minimize efforts, reduce documentation and to promote least burdensome approach to maintaining the QMS.Serve as Senior Quality Approver for the validation processes.Provide quality and regulatory oversight and review during the qualification/validation planning process.Review and approve plans, reports and data generated to qualify processes, equipment and computer systems.Ensure corporate documents are adopted and maintained.Perform compliance reviews of validation protocols and final reports in support of validation effort.Support, generate and execute validation of quality management system improvement processes.Lead data analytics efforts to identify trends, systemic issues and opportunities for process improvements:Collect analyze and interpret quality data to support management reviews and regulatory reportingPrepare trend analysis for NCs, CAPAS, complaints and other quality metrics.Prepare summary reports and presentations to highlight performance indicators , recurring issues and opportunities for improvement.Perform monthly Quality System Checks and organize periodic Quality Meetings.Champion changes in quality metrics, help introduce future metrics and trend reports, improve ease of reporting and ensure accurate and consistent metrics.Ensure all quality decisions are risk-based, data-driven and aligned with patient safety and product quality.Create and/or update QMS procedures. Maintains procedures relevant to scope of job description. Reviews and approves facility wide documents to ensure compliance with regulatory objectives and change guidelines.Actively participate in third party audits as well as internal audits. Support the audit program by actively participating as a lead auditor. Support third party audits by providing documentation and quality data as a senior subject matter expert.Act as a change champion, promoting the culture of quality, accountability and continuous improvement across all levels.Collaborate cross-functionally with Process Engineering, Production and Supply Chain to ensure timely closure of quality events.Balance a multiplicity of demands in a responsive, professional manner to assure the quality assurance systems organization provides appropriate and timely support to meet business objectives.Perform other related duties and assignments as required. Your Qualifications: Minimum Bachelor's degree in the sciences or engineering. Master's degree preferred.At least fifteen years of relevant work experience in Quality Assurance/Regulatory Compliance within the medical devices or life sciences industry.Familiarity with interpreting regulations as they relate to quality systems. Strong expertise in FDA QSR,ISO13485 and Risk Management standards preferred.Exceptional organizational skills and ability to plan and implement resolutions to problems. Proven project managementAbility to demonstrate achievements within a competitive manufacturing environment where change plays a major role. Proven track record of results.Excellent interpersonal skills with the ability to interact and influence others to complete mutually agreed tasks per scheduleAbility to effectively manage time to meet assigned deadlines and prioritize multiple work assignments. Ability to work independently with minimal supervision.Excellent writing skills.Previous audit experience, RAC or CQE certification.Computer literate in Microsoft Word, Excel, Access, and working knowledge of Windows. Advanced proficiency in data analytics tools (Excel, Minitab, Business Intelligence)Knowledge of business management systems such as SAP, LABSQ and QUMAS

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