Quality Assurance Expert

Location

Somerset, NJ (Hybrid)

• 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 the 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 reporting.
  • Prepare 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. Maintain procedures relevant to scope of job description. Review and approve 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.

• 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, ISO
  13485 and Risk Management standards preferred.
• Exceptional organizational skills and ability to plan and implement resolutions to problems. Proven project management experience.
• Ability 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 schedule.
• Ability 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.

• Ability to sit or stand for up to 8 hours per day, view computer monitor and move about between departments and buildings to effectively fulfill the essential functions…