Quality Manager

This role is responsible for ensuring our products and processes meet customer expectations and applying knowledge of systems to drive improvement and consistent quality standards in partnership with our operations teams. This will be achieved by leveraging an understanding of best practices in a Quality Management System, Lean tools and concepts, and driving the culture that supports our core values. This role will assist in the development and sustainment of our quality goals, lead the quality teams, ensure compliance with our QMS and company policies, establish key measurable standards, identify root causes, and develop and track corrective actions.

Core Responsibilities

1. Manage the QE and QA teams and processes within the Quality Management System across all locations.
2. Support an operating culture that promotes responsiveness, communication, trust & integrity, safety, leadership by going first, passion to win, celebrating together, and respect – our core values.
3. This will require people first leadership approach and strong change management and project management skills, while driving adherence, compliance, and accountability across the organization.
4. Strong collaboration and influencing skills to ensure cross-functional teams and leaders focus on operational effectiveness and efficiency, and development and sustainment of our quality goals.
5. Strong problem-solving skills are used to identify root causes and used to develop and track corrective and preventative actions.

ESSENTIAL FUNCTIONS AND BASIC DUTIES:

• Define and develop quality procedures and specifications, standards, testing, and inspection and identify and execute or lead kaizen events and improvement projects around these opportunities.
• Identify opportunities to enhance or supplement existing technologies through collaboration with internal and external stakeholders to advance processes and automation.
• Effectively communicate significant issues or developments identified during quality assurance activities and provide recommended process improvements or solutions.
• Promptly resolve customer concerns and escalate as needed.
• Responsible for customer warranty claims processing and resolving quality concerns.
• Responsible for corrective action activities internally and externally with all suppliers and customers.
• Supplier inspection and testing of materials, parts, and products to ensure adherence to standards.
• Supplier Approval Process - Assessments, Audits and Approval for purchased products and components.
• Collaborate with the finance data and analytics team to prepare operational performance reports to provide insights to leadership and employees; monitor performance, workload, and resource reports.
• Use data and metrics to identify opportunities to improve safety, internal quality, the external customer experience, delivery, cost, and growth.
• Remove waste from operational processes and create KPI's for pro-actively monitoring the efficiency and effectiveness of processes.
• Develop strong working relationships with key internal and external stakeholders and customers.
• Develop and facilitate training, coaching, and mentoring of teams, ranging from management to operators, to facilitate Lean and Quality Assurance culture.
• Support operations and quality teams where needed in relation to problem solving, gap improving, and process knowledge where needed.
• Collaborate with executive management in determining departmental organizational plan, operating model, strategy deployment and governance procedures as needed.
• Travel to all company sites and customer/vendor sites as needed.
• Performs related work as apparent or assigned.

EDUCATION/CERTIFICATION:

• Four-year degree in a scientific, engineering, or related technical field.
• 4+ years of Quality or Regulatory Experience.
• Familiarity and exposure to FDA, ISO and AS9100 systems desired.
• Prior experience in a manufacturing environment preferred.
• Knowledge of SPC, GD&T, FMEA, DOE.
• Advanced degree and/or professional certification in quality/regulatory/compliance preferred.

EXPERIENCE REQUIRED:

• Demonstrated history of successful quality and compliance organizational leadership and successful achievement of organizational business objectives.
• Demonstrated success of change management across multiple teams and levels of an organization
• Strong written and verbal communication skills.
• Ability to explain and resolve differences in interpretation of customer requirements, standards, regulations, and quality system requirements.
• Demonstrated experience in development, deployment and execution of quality and compliance.
• A demonstrated ability to get things done via indirect leadership and influence. This role will require a self-motivated business leader with a high sense of urgency and the ability to train, coach and mentor leaders within the organization in structured problem-solving techniques and philosophies.

SKILLS ABILITIES: Strong leadership and sound decision-making capabilities. Ability to communicate effectively, both orally and in writing, with a wide variety of company personnel and positions.
PHYSICAL STRENGTH: Mobility within the work facility. Communicating with others both verbal and written.
LANGUAGE ABILITY: English