Extremity Care
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
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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
#J-18808-Ljbffr