Senior Specialist Quality Assurance

What You'll Work On

• Defines project goals and milestones. Responsible for timely project completion.
• Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant, innovative, thorough, practical and consistent with organizational objectives.
• May lead projects with cross-functional or broader scope.
• Interacts effectively with employees, manager, and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders.
• Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.
• Communicates confidently and effectively with management, peers, and key stakeholders.
• Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly.
• Directly influences project direction and scope. Scope includes one or more QA functions, with general knowledge of other related disciplines.

Quality System Compliance

• Demonstrates good, general understanding of the standards and regulatory bodies that regulate our industry.
• Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
• Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
• Leads quality system activities including CAPA, nonconformance investigations, root cause analysis, effectiveness verification, and implementation of sustainable corrective actions.
• Identifies trends and continuous improvement opportunities to ensure ongoing compliance and process effectiveness.
• Analyzes quality system data, including complaints, nonconformances, CAPAs, audits, supplier performance, and post-market surveillance information to identify trends and assess effectiveness of quality processes.
• Monitors and interprets evolving regulatory requirements, standards, and industry expectations; performs impact assessments and partners with cross-functional teams to implement compliant solutions and maintain inspection readiness.
• Serves as a Quality Systems SME by providing training, mentoring, and guidance on quality processes, regulatory requirements, investigations, CAPA activities, and continuous improvement initiatives.