Job Overview

The Quality Manager is responsible for leading the site's end-to-end quality strategy and execution, ensuring compliance with customer, regulatory, and industry requirements. This role will drive the adoption and integration of the company's Quality Management System (QMS) within the Rochester facility while maintaining regulatory compliance, supporting ISO registration/certification activities, and fostering a culture of continuous improvement.

The Quality Manager will partner cross-functionally with Operations, Engineering, Supply Chain, and Leadership to ensure products and processes consistently meet quality standards and customer expectations.

Please note: operations are currently based at a temporary site in Webster, NY. The team will transition to a permanent Rochester location (near RIT) upon completion.

Job Requirements

Quality Management System (QMS)
•    Lead the implementation, adoption, and ongoing management of the company's Quality Management System at the Rochester site.
•    Ensure site processes, procedures, and work instructions are aligned with corporate quality standards and applicable regulatory requirements.
•    Develop, maintain, and improve quality policies, procedures, and documentation.
•    Drive standardization and best-practice sharing across functions.

Regulatory Compliance & Certification
•    Ensure compliance with all applicable regulatory, customer, and industry requirements.
•    Lead and maintain ISO certification/registration activities (e.g., ISO 9001 and other applicable standards).
•    Serve as the primary site contact for external certification bodies and regulatory agencies.
•    Coordinate site readiness for audits, inspections, and compliance reviews.

Quality Assurance & Continuous Improvement
•    Establish and monitor quality metrics, KPIs, and reporting mechanisms.
•    Lead root cause investigations, corrective actions (CAPA), and preventive actions.
•    Drive continuous improvement initiatives utilizing Lean, Six Sigma, and other quality methodologies.
•    Analyze quality trends and develop action plans to improve performance and reduce risk.

Audits & Risk Management
•    Plan and execute internal quality audits.
•    Lead responses to customer, regulatory, and certification audits.
•    Identify quality risks and implement mitigation strategies.
•    Ensure timely closure of audit findings and corrective actions.

Customer & Supplier Quality
•    Serve as the primary escalation point for significant quality issues.
•    Partner with customers to address quality concerns and improve satisfaction.
•    Support supplier qualification, supplier quality performance management, and corrective action activities.
•    Monitor and improve incoming, in-process, and outgoing quality performance.

Leadership & Team Development
•    Lead, coach, and develop quality personnel.
•    Build a culture focused on quality excellence, accountability, and compliance.
•    Provide quality guidance and training to site employees.
•    Collaborate with leadership to align quality objectives with business goals.

What your background should look like

• Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or a related technical field.
• 10+ years of progressive quality leadership experience in a regulated manufacturing environment.
• Strong experience implementing and managing Quality Management Systems (QMS).
• Experience leading ISO certification and surveillance audits.
• Demonstrated knowledge of quality methodologies, CAPA, root cause analysis, and continuous improvement tools.
• Experience managing customer, regulatory, and certification audits.
• Strong leadership, communication, and project management skills.

Preferred

• Master's degree in a related field.
• ASQ certifications (CQE, CQM/OE, CSSBB, or equivalent).
• Experience with Lean Manufacturing and Six Sigma methodologies.
• Experience leading quality transformations across multiple sites or business units.

Competencies