Director of Quality

Director of Quality

Summary

The Director of Quality Assurance is responsible for developing and directing robust quality processes and procedures to ensure the products manufactured meet customer requirements and specifications, including FDA, ISO 13485 and AS compliance, as applicable. This position will develop and grow a capable team of quality assurance staff to achieve company goals and objectives.

Primary Duties

• Lead as the management representative for FDA 21 CFR 820, ISO 13485 and AS certifications
• Responsible for creation, implementation and maintenance of the Quality System processes, in compliance FDA 21 CFR, Part 820, Quality System Regulation and ISO 13485
• Systems include Corrective and Preventive Action, Non-conformance and Material Review Board, Validation and Qualification, Management Review, Document and Record Control, Risk Management Activities, Training and Resource Management, Supplier Management, Internal Audit System, Calibration, Inspection and Inspection Planning, RMA and resolve of customer complaints.
• Establish and promote a work environment that supports the company Quality Policy, Quality Objectives and Quality System.
• Develop and implement policies, procedures, and systems that support company quality goals and objectives, and maintain regulatory compliance.
• Recruit, train and manage quality control and assurance personnel including inspection and metrology.
• Provide direction, coaching and development of quality personnel.
• Lead MRB and CAPA process to reduce product non-conformances through training and effective corrective actions.
• Investigate and manage customer complaints with internal and external customers to solve quality issues through the CAPA process.
• Provide leadership on continuous improvement initiatives (lean, Six Sigma, etc.)
• Monitor and report internal and external quality metrics by collecting, analyzing, and summarizing information and trends.
• Maintain validation and calibration of inspection equipment.
• Organize customer quality expectation information and contractual obligations.
• Participate in creation of DMR. Specifically assure the development of part specific inspection plans to meet customer requirements and contractual obligations.
• Develop robust, part specific, inspection processes that meet customer requirements.
• Train all employees on quality & safety procedures & monitor performance
• Support a safety-oriented culture within the company
• Participate in the development of the company’s strategic planning, vision, mission and values and desired culture

Required Education and Experience:

• Bachelor’s degree in Quality, Engineering, or a related technical field preferred
• Minimum 10 years experiencing in a manufacturing environment with 5 years’ experience in progressive leadership and management roles in a contract manufacturing environment preferred
• Excellent communication and organizational skills
• Ability to work in a fast-paced environment with multiple priorities
• Demonstrated leadership behaviors including effective communication, critical thinking and decision making, change agent and a strong sense of urgency
• Proven experience leading continuous improvement initiatives
• Experience utilizing problem solving and root cause analysis methods
• Green Belt or Black Belt certification preferred
• Lead Quality Auditor training
• Experience as a management representative with FDA 21 CFR 820, ISO 13485 and/or AS9100
• High proficiency in use of computer programs including Outlook, Excel, Word, ERP, etc.
• Experience working with QMS and ERP systems i.e., Epicor ERP

Necessary Skills, Abilities and Knowledge:

• Thorough knowledge and understanding of Quality philosophies, principles, methods, and tools
• Knowledge and understanding of ISO 13485 and 21 CFR Part 820
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint
• Ability to communicate extremely well across all levels and departments of a business
• Drive organizational change
• Ability to lead and develop personnel
• Strong interpersonal skills Self-motivated with high degree of accountability
• Strong Analytical skills and the ability to express concepts effectively, both written and verbal
• Highly skilled in decision making and problem solving
• Financial Management and Business Acumen minded
• Change agent and ability to work with a diverse group of people
• Strong managerial leadership and communication proficiency with the ability to motivate and lead others.
• Hands on experience with ERP and Quality System software preferred