Director of Quality

Director Of Quality

The Director Of Quality is responsible for overseeing the quality management system and quality operations, to include document control, quality event investigations, customer feedback/complaints, design control, risk management, and quality control, while ensuring compliance with established standard operating procedures, FDA regulations, AATB Standards, ISO standards and other application regulations and industry standards.

Responsibilities

• Define and promote a quality mindset throughout the organization
• Develop, implement, and maintain procedures and controlled documents according to FDA regulations, AATB Standards, ISO Standards, and other applicable regulations
• Provide subject matter expertise to drive improvements and decisions relating to the quality management system while supporting organizational strategic objectives
• Oversee management of change control, the document change system, design control, record control, and periodic review of controlled documents and perform associated quality approvals
• Lead training of new processes, process revisions, and corrective actions relating to quality
• Oversee management and coordination of training requirements/assignments
• Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, supply inspections, and device/product inspections
• Oversee management of deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations
• Ensure adequacy of investigations with respect to root cause analysis and CAPA assessment
• Conduct quality review and approval for closure of deviations, nonconformances, complaints, CAPAs, and SCARS
• Lead risk management of department and ensure risks/issues are identified, addressed/reported, and where appropriate, escalated
• Oversee, lead, and manage quality system related meetings including management review
• Establish, evaluate, report, and provide improvements (where appropriate) for quality metrics
• Provide quality oversight, support, and approval for new projects and products
• Collaborate, review, and approve validation/verification/qualification plans, protocols, execution data, and summary assessments
• Oversee and manage use of quality system software(s)
• Support documentation requests from regulatory affairs department to support regulatory submissions (e.g. PMA supplements, 510(k) submissions)
• Direct, participate, and/or support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and standard operating procedures
• Analyze data by conducting hypothesis, normal distribution, and process capability analysis testing
• Develop and maintain professional working relationships with current and potential customers, consultants, suppliers, and vendors
• Establish and execute continuing education strategy for department
• Maintains company compliance and a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
• Manage direct reports
• Provide constructive feedback and guidance to develop leadership in direct reports and department management
• Establish and monitor objective annual goals for direct reports
• Conduct performance reviews and establish performance improvement plans as needed
• Recruit, interview, and select personnel for hire
• Travel domestically up to 25% to attend offsite meetings, conferences, and support business initiatives
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings
• Ensure completion of assigned tasks and responsibilities within defined timeframes
• Maintain flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
• Perform other duties as assigned

Skills

• Knowledge of FDA's Quality System Regulations, and the Canadian Medical Device Regulations
• Ability to manage multiple complex problems simultaneously
• Ability to be flexible in changing daily workload priorities as directed
• Ability to coordinate and synchronize multiple projects
• Ability to conduct a significant amount of planning activities for self and others
• Ability to take initiative and make decisions within company/departmental guidelines
• Ability to thrive under challenging deadlines and in an energetic environment
• Ability to work independently and in a team environment
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Highest level of ethics and integrity
• Ability to lead and motivate the right behaviors
• Strong technical writing
• Effective project management
• Proficiency in Microsoft Office

Qualifications/Requirements

• Bachelor's degree in a biological science, engineering, or related field required
• Master's degree in a biological science, engineering, or related field preferred
• At least 5-7 years of experience in an FDA regulated environment for medical device and/or pharmaceutical manufacturing, with at least 3-5 years in a management role for quality assurance, regulatory affairs, and/or engineering
• ASQ CQE certification preferred
• Must have DOE, Statistical Analysis, Quality System implementation, Quality Engineering Techniques, IQ/OQ/PQ, QSR (GMP) and ISO experience. Knowledge of basic statistical and engineering principles is essential
• Clearance of favorable background investigation required