Quality Manager

About the role

The Quality Manager is responsible for maintaining and continuously improving Equilibar’s Quality Management System (QMS) to ensure our products, processes, and customer solutions consistently meet internal, regulatory, and customer requirements. This position works across Engineering, Production, Customer Support, and other teams to identify quality issues, determine root causes, implement effective corrective actions, and ensure learnings are incorporated into the organization. The Quality Manager serves as a key resource and responsibility for quality-related problem solving, documentation, audits, and continuous improvement, training, and safety. This position also supports customers with quality and compliance requirements, including customers in highly regulated industries such as biopharmaceutical manufacturing. Success in this role requires a hands-on approach, strong technical problem-solving skills, attention to detail, and the ability to work collaboratively across the organization. Success also includes strong audit performance, conformance to applicable quality and customer requirements, accurate and useful documentation, timely follow-up on quality actions, and effective development of the quality team. Most importantly, the role helps build a culture where quality is used to solve problems, improve processes, and consistently deliver products and solutions that meet or exceed customer expectations.

Responsibilities

Quality Management System

• Maintain and support Equilibar’s QMS and ensure established quality processes are being consistently followed and remain effective.
• Coordinate required quality activities, meetings, reviews, and documentation and support programs related to internal audits, verification, corrective and preventive actions, risk management, continuous improvement, training, safety, management review and environmental requirements.
• Work with process owners to identify gaps, follow up on required actions, and ensure quality issues are appropriately addressed.

Root Cause, Corrective Action & Continuous Improvement

• Facilitate the investigation of quality issues and customer concerns using structured root-cause analysis and problem-solving methods.
• Work with Engineering, Manufacturing, Customer Support, and other teams to develop and implement corrective actions, verify their effectiveness, and identify opportunities to prevent recurrence.
• Review customer support cases and recurring issues to identify trends, determine when additional investigation or escalation is needed, and ensure important learnings are captured and communicated.

Audits & Quality Compliance

• Coordinate internal and external quality audits and serve as primary contact with Equilibar’s certification and registration bodies.
• Maintain awareness of applicable quality standards, regulations, and industry practices and ensure required audits, documentation, training, and follow-up activities are completed.
• Support process owners in addressing audit observations and implementing corrective actions.
• Support customer quality reviews, questionnaires, audits, and requests for quality documentation, with particular attention to customers operating in regulated industries such as biopharmaceutical and pharmaceutical manufacturing.
• Work with customers and internal teams to understand applicable quality expectations and demonstrate conformance to required industry standards and customer-specific requirements.
• Coordinate responses to customer audit findings and quality concerns and ensure appropriate corrective actions and supporting documentation are completed.

Supplier Quality & Performance

• Work with Purchasing, Engineering, Manufacturing, and suppliers to improve the quality and consistency of purchased components and services.
• Monitor supplier quality performance, investigate recurring or significant supplier issues, and coordinate corrective actions when needed.
• Communicate quality expectations to suppliers, follow up on nonconformances, and help ensure supplier improvements are effective and sustained.

Quality Leadership & Cross-Functional Support

• Lead and develop direct reports while working closely with Engineering, Manufacturing, Customer Support, Operations, and other teams to resolve quality issues and improve processes.
• Provide coaching and quality expertise in areas such as root-cause analysis, corrective actions, auditing, risk assessment, Lean manufacturing, and continuous improvement.
• Encourage ownership, collaboration, problem-solving, and ongoing professional development across the quality team and organization.

Qualifications

• Experience leading or developing quality personnel.
• Experience managing or administering an ISO-based Quality Management System in an engineering or manufacturing environment.
• Experience with root-cause analysis, corrective actions, nonconformances, and continuous improvement.
• Experience conducting or supporting internal and external quality audits.
• Strong technical problem-solving and analytical skills.
• Strong written and verbal communication skills.
• Ability to work effectively with Engineering, Manufacturing, customers, suppliers, and other cross-functional teams.
• Experience maintaining quality documentation and records.
• Ability to organize and follow through on multiple quality activities and corrective actions simultaneously.
• Bachelor’s degree in engineering, business, or related field; advanced degree preferred.
• Experience with pharmaceutical, biopharmaceutical, life sciences, or other regulated-industry customers.
• Familiarity with GMP and customer-specific quality requirements.

Personal Characteristics

• Organized and detail-oriented
• Collaborative and approachable
• Curious and analytical
• Comfortable challenging existing processes
• Strong sense of ownership and follow-through
• Committed to Continuous Improvement
• Outstanding Problem Solver
• Able to balance customer, technical, and business needs
• Motivated to develop and mentor others
• Committed to safe and responsible work practices
• Adaptable, able to thrive in a dynamic work environment