As the Sr. Director of Quality, you will be a part of IRRAS' Leadership team with the primary responsibility of developing and implementing Quality Systems. The role is strategically important for the success of commercialization goals, ensuring continuous improvement and high-quality devices enter emerging, regulated, and global markets. You will serve as the subject matter expert to the executive team and provide guidance in areas related to quality, compliance, regulations, and clinical documentation for global registration. By working closely with the leaders of the company across all departments, this position will introduce and lead transformational efforts for improving product quality and driving a culture of quality throughout the company.
The hands-on Quality and Regulatory representative will be responsible for managing a team of quality professionals assessing their performance and providing guidance for further individual development and setting goals for the function.
· Responsible for development, implementation, maintenance, and overall success of the company’s quality and regulatory programs and strategies, including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing processes, establishing vendor relationships and quality standards, and developing and implementing innovative programs to focus employees on improving product quality
· Ensure the Quality System is effectively established, implemented and maintained in accordance with applicable standards.
· Develop and support design transfer activities by implementing standardized quality centric launch practices that enable business strategies.
· Create and promote Quality and regulatory awareness level as determined within the organization.
· Act as a contact person for ongoing NPD Projects to make sure to provide right amount of resources.
· Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle.
· Ensure compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
· Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications.
· Oversee all inspections and questions relating to the Quality operation of our contract manufacturer.
· Oversee the performance of internal and external audits
· Review, edit, and maintain all departmental policies, procedures, and trainings.
· Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and processes.
· Support and attend to internal and external Audits for the organization.
· Manage IRRAS Quality events - deviations, non-conformances, CAPAs, customer complaints, process change controls, recalls, etc.
· Evaluate deviations, non-conformances, out of specifications, customer complaints and process change controls for completeness and impact on product quality.
· Review, consult, and approve risk analysis performed for COs, NCMRs, recalls, etc.
· Work with operations on the implementation of process programs and controls.
· Investigate and works with other departments to resolve quality issues related to area assigned.
· Review records and data for product release.
· Oversee Quality system training and lead development of training programs regarding all aspects of producing quality products.
· Performs trending of established quality metrics.
· Act as an agent of positive change, innovation and continuous quality improvement, with the ability to influence across functions.
· Plan and schedule projects in a manner consistent with corporate objectives.
· Work with product development staff to ensure that products under development are compliant with FDA and ISO requirements.
· May perform additional duties as assigned or directed by management from time to time
· Bachelor's degree in life science or related field or the equivalent combination of education and/or experience. Engineering degree preferred.
· 10+ years' experience in biotech or Medical Device/IVD industries (GMP regulated environment) working in a QA/RA leadership role.
· Extensive experience hosting regulatory inspections and interacting with regulators.
· Strong understanding of global registration requirements and demonstrated track record of successful market access.
· Experience with computer software validation (CSV) and implementation for QMS and ERP software packages, including user requirements gathering and specification development, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution.
· General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices.
· Effective manager with ability to mentor and develop members of the QA/RA teams through coaching and effective performance management.
· Proven ability to create culture of accountability and ownership.
· High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
· Excellent communications and presentation skills.
· Ability to develop and manage a high-performance team focused on accountability and meeting and exceeding expectations.
· Ability to lead, influence, create and work within cross-functional team environments.
· Assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done.
· Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments.
· Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
· Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry.
· Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
· Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
· Confidence - Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
· Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.
· The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
· Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
· The employee might occasionally lift and/or move up to 25 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· General office environment.
· Daily exposure to PCs and networks.
· The noise level in the work environment is usually moderate.
· Travel will be required.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.