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 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. 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 management
• 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.

Physical Demands:

• 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 of the job.

Equipment & Machinery Used:

• Desktop or lap top computer.

Benefits Offered

• Medical plan
• Prescription drug coverage
• Dental plan
• Retirement savings plan
• Disability benefits
• Flexible spending