Director, Quality Assurance

Position Summary

Core Responsibilities

• Management Representative with the authority and responsibility for ensuring the quality system requirements are effectively established, implemented and maintained; reporting on the performance of the quality system, and any need for improvement, to executive management; and ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.
• Oversee day to day operations and provide strategic/operational direction for the Company’s Quality Assurance department including management and development of QA personnel, final product testing and release, receiving and in-process testing, stability testing, QC inspections and audits, and QC documentation.
• Jointly responsible with the Vice President, Regulatory & Clinical Affairs to serve as PRRC (person responsible for regulatory compliance) as defined in the European Medical Device Regulation 2017/745.
• Develop and implement effective internal quality policies, procedures, and training programs consistent with Company objectives, customer needs, and FDA QSR/ cGMPs, ISO 13485 regulations, and CE marking guidelines.
• Analyze, develop, implement, and audit policies and procedures for applicability and compliance to regulations.
• Responsible for company-wide quality system procedures for executing how the company handles process validation, process control and enhancements, quality metric reporting, supplier qualification, design assurance programs, complaint handling and CAPA programs.
• Manage material control program to include: QC materials management including labeling and storage, QC materials inventory and use and materials lot control.
• Support engineering in the development, testing, verification, validation, and commercialization of new products, or changes to existing products to assure products conform to government and Company standards and satisfies all applicable regulations.
• Support engineering in the qualification and validation of equipment and processes.
• Develop, coordinate, and administer internal and third-party quality audits, inclusive of schedules, communication, reports, and tracking follow-up actions.
• Interface with the FDA, ISO, CE, and other international regulatory agents or surveillance auditors. Respond to regulatory and/or third-party audit observations.
• Develop and implement instructions/methods for inspecting, testing, and evaluating product conformance to specification.
• Process non-conforming material reports including MRB dispositioning. Work with suppliers to correct problems.
• Maintain the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion, and periodic reports and metrics.
• Support manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to avoid recurrence. Lead and perform component/product testing.
• Responsible for the deployment, validation, and maintenance of the Quality Management System software.
• Maintain the product stability program, including both real time and accelerated aging.
• Evaluate quality data, prepare periodic reports to monitor trends, and report to management to ensure the Company’s continuous improvement efforts are on track.
• Review and approve reports and other documentation prepared by QA and QC for regulatory submissions/inspections.
• Act as primary quality team member for projects and product teams, providing counsel, training, and interpretation of FDA and other applicable regulations to Company personnel.
• Participate in risk analysis to identify appropriate protective measures to mitigate risk associated with identified hazards.

Qualifications

• Bachelor’s degree in Engineering, Science or related field degree
• 8+ years experience in Quality Assurance, Quality Engineering, or related functions in a medical device or FDA regulated company
• Good working knowledge of FDA Quality System Regulation 21 CFR Part 820 (cGMP/QSR) and related parts, 21 CFR Part 58 (GLPs), ISO 13485, 93/42/EEC (EU Medical Device Directive) and MEDDEV 2.12 (Medical Device Vigilance Guideline)
• Good organizational and follow-through skills with exceptional attention to detail
• Excellent verbal and written communication skills
• Demonstrated presentation, facilitation skills and the ability to interact and communicate with senior management and technical staff at all levels
• Understanding of statistics required – Cp, Cpk, AQL, etc.

• Startup or early-stage medical device experience.
• ASQ, CQM (Certified Quality Manager) or CQE (Certified Quality Engineer) are highly desirable.
• Class III Medical Device experience