QA Supervisor

QA Supervisor – DHR Review

The QA Supervisor – DHR Review plays a pivotal role in maintaining the integrity and effectiveness of the Quality System by overseeing Device History Record (DHR) review activities and leading the team of DHR Reviewers. This position supervises daily operations, drives process improvements, and ensures compliance with applicable medical device regulations while supporting internal stakeholders and regulatory audits.

• Supervise and oversee DHR Review areas within the Quality System, ensuring consistent, compliant, and timely review of Device History Records.
• Select, manage, train, and develop staff, fostering a high-performing team culture focused on quality, accuracy, and continuous improvement.
• Establish clear objectives and assignments for team members and provide ongoing feedback through performance reviews and individual development plans.
• Manage the scheduling of DHR Reviewers to ensure appropriate coverage, prioritization, and balanced workload across all review activities.
• Coordinate with internal customers to establish prioritizations, resolve discrepancies, and support cross-functional collaboration.
• Communicate process changes to internal customers and provide training to ensure proper understanding and adoption of updated procedures.
• Perform DHR reviews personally when needed to support throughput, quality, and team workload.
• Analyze and generate trending data related to DHR and Quality System performance to monitor effectiveness and identify opportunities for improvement.
• Evaluate procedures and work instructions to identify processing improvements and implement changes as necessary to enhance efficiency and compliance.
• Support Quality System processes during internal and external regulatory audits by providing documentation, explanations, and evidence of compliance.
• Proactively seek system improvements while maintaining strict adherence to applicable medical device regulations and quality requirements.
• Communicate Quality System issues to upper management in a clear, solution-oriented manner, presenting recommendations and action plans as appropriate.
• Ensure a high degree of accuracy and attention to detail in all DHR and quality-related activities.
• Prioritize and manage multiple assignments simultaneously, maintaining strong organizational control over team tasks and deadlines.

• Bachelor's degree with at least 2 years of relevant experience, or an equivalent combination of demonstrated education and experience.
• Demonstrated working knowledge of medical device regulations and associated Quality System requirements.
• Solid problem-solving and decision-making skills, with the ability to address complex quality and process issues effectively.
• Supervisory skills with experience leading, guiding, and developing staff in a quality-focused environment.
• High degree of accuracy and attention to detail in reviewing records and documentation.
• Excellent organizational skills, with the ability to prioritize assignments and manage various tasks simultaneously.
• Proficiency with Microsoft Office applications, including Word, Excel, Access, and PowerPoint.
• Ability and willingness to work on site during standard business hours.
• Capability to lift and move items up to 25 pounds as needed.
• Ability to move between buildings and floors to access work areas and resources.
• Ability to remain stationary and use a computer or other standard office equipment, such as printers and copy machines, for extended periods each day.
• Ability to read, prepare emails, and produce documents and spreadsheets accurately and efficiently.
• Ability to move within the office environment to access file cabinets, supplies, and other resources as needed.

• Prior supervisory experience in a quality assurance or related environment is preferred.
• Experience working within a Quality Management System (QMS), particularly in medical device or regulated industries.
• Strong leadership capabilities with the ability to coach, mentor, and develop team members.
• Effective communication skills, including the ability to present quality issues and solutions to upper management and…