Director of Quality Engineering

Purpose

The Director of Quality Engineering is responsible for oversight of quality engineering activities in product development, lifecycle management, and quality tools and systems. Specifically, this encompasses quality oversight in design control, design verification/validation, design history files, and risk assessment to ensure compliance with established standard operating procedures, FDA regulations, AATB Standards, ISO standards and other applicable regulations and industry standards. This role is responsible for driving best practices in quality engineering and collaborating cross functionally across the organization.

Responsibilities

• Develop and implement a quality engineering strategy aligned with product development goals and business priorities
• Implement and lead risk management activities for new product development, including FMEA, fault tree analysis, and hazard analysis
• Oversee quality engineering support for research and new product development in design control, process validation, and risk management activities throughout the product lifecycle
• Ensure effective design history file impact assessment for product and process changes for and serve as final reviewer and approver
• Ensure robust statistical analysis is applied to support process capability, control plans, and quality metrics
• Cross functionally collaborates on the review and approval of validation/verification/qualification plans, protocols, execution data, and summary assessments
• Oversee Quality Engineering support in design reviews
• Collaborate in the risk assessment for material, process, and product changes
• Support documentation requests from regulatory affairs department to support regulatory submissions (e.g. PMA supplements, 510(k) submissions)
• Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, accreditation/certification requirements, and internal policies and standard operating procedures
• 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 8-10 years of experience in an FDA regulated environment for medical device and/or pharmaceutical manufacturing, with at least 5 years in a management role for quality assurance, regulatory affairs, and/or engineering
• Certified Six Sigma Black Belt 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