Lead Quality Systems Analyst

About the position

We are seeking an experienced Quality Systems Analyst. This role is responsible for providing expert guidance and leadership in quality audit processes, the administration of quality management and other command media systems, along with managing the scheduling and execution of internal and external audits. The successful candidate will apply their broad expertise and knowledge in quality assurance, quality audits, and quality systems administration to ensure compliance and continuous improvement within our operations.

Responsibilities

• Contribute to the development and execution of company objectives related to quality management and system administration.
• Conduct quality audits, ensuring adherence to internal standards, industry regulations, and external compliance requirements.
• Manage the scheduling of internal/external audits, ensuring audits are conducted on time and in accordance with the established quality audit plan.
• Coordinate audit resources, ensuring proper allocation of staff and tools for effective audit execution.
• Evaluate operations, data, and other factors to identify opportunities for process improvement and mitigate risks.
• Develop and maintain formal networks with various departments and stakeholders, ensuring alignment across groups and contributing to broader organizational projects.
• Ensure that quality systems are robust, effective, and continuously evolving, maintaining compliance with regulatory standards.
• Drive initiatives that influence wider business processes, with a focus on quality management system integration and audit function optimization.
• Present complex information clearly to diverse stakeholders, influencing decisions and ensuring that quality principles are understood and adhered to across all levels of the organization.
• Serve as the recognized subject matter expert within the business unit on quality systems and audits, offering advice and solutions to complex quality-related issues.
• Support development of Program Quality Plan and site Quality Metrics.
• Participate as a member of the Material Review Board team and Change Control Board and lead proposed corrective actions.
• Perform Program Process Evaluations (PPEs).

Requirements

• 8 years of related experience with a Bachelor’s degree in a relevant field; or 5 years and a Master’s degree.
• Strong experience in quality audits, quality audit scheduling, and the administration of quality management systems.
• Proven experience managing and executing audit schedules, ensuring audits are planned, resourced, and completed efficiently.
• Proven ability to analyze complex data and situations, providing strategic insights and recommendations to senior management.
• Excellent communication and interpersonal skills, capable of influencing diverse stakeholders across the organization.
• Must have experience with ISO9001/AS9100 Quality Systems.

Nice-to-haves

• Previous experience in industries with highly regulated environments (e.g., healthcare, manufacturing, or pharmaceuticals).
• Strong understanding of risk management, process optimization, and change management in quality systems.
• Experience with audit management software or scheduling tools.
• Strategic Thinking and Problem Solving.
• Communication and Stakeholder Engagement.
• Process Improvement and Systems Integration.

Benefits

• Medical, vision and dental insurance for employees and dependents.
• Paid time off including: minimum of 3 weeks vacation, 5 floating holidays, 8 designated holidays, parental leave, personal illness, bereavement, jury duty, long-term and short-term disability.
• 401(k) with immediate vesting on employer match.
• Tuition assistance.
• Student loan assistance.
• Wellness account, Care.com subscription and employee assistance programs.
• Employee stock purchase program with employer match.