Quality Control Supervisor

Quality Control Supervisor

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Quality Control Supervisor will manage and oversee the quality control activities related to receiving inspection, product returns, and nonconformance management. This role ensures compliance with regulatory standards and internal quality requirements, driving continuous improvement in product quality and operational efficiency. This role is a working supervisor who will support their direct team with hands on NCMR analysis, returns analysis and receiving inspection as needed. Assists Quality Engineering with data gathering/analysis and QMS maintenance.

Accountabilities & Responsibilities

• Supervise, coordinate, and prioritize daily activities of Quality Inspectors and Quality Technicians responsible for nonconformance, product returns and receiving inspection to meet production and quality objectives
• Provide training, coaching, and performance feedback while ensuring adherence to procedures and Good Documentation Practices
• Serve as a hands-on leader by acting as a backup and float across quality inspection and technician functions
• Maintain and monitor Quality Metrics associated with receiving inspection and nonconformance to ensure performance targets are met
• Manage receiving inspection and returned product queues to ensure priority items are completed in a timely manner and target metrics are maintained
• Perform and support incoming, in-process, and final inspection, including testing, measurement, and product evaluation
• Lead and support non-conforming material processes, including documentation, investigation, disposition, and escalation
• Lead and support processing and investigation of product returns, ensuring proper documentation and analysis.
• Support development and review of procedures associated with Quality Control.
• Ensure compliance with QMS, HIPAA, and regulatory requirements (e.g., 21 CFR 820, ISO 13485)
• Identify and lead continuous improvement initiatives using data analysis, trend monitoring, and operational insights to identify areas of improvement and lead continuous improvement projects
• Other duties as assigned

Qualifications Required

• Associates degree or equivalent work experience in a related discipline
• Minimum of 1 year of leadership or lead experience or demonstrated leadership capability
• Minimum of 5 years' experience working in a regulated manufacturing environment (at least 2 years of that time must in medical device under ISO 13485).
• Strong working knowledge of inspection, testing, and quality processes
• Familiarity with Excel for compilation/trending of data.
• Knowledge of GXP, 21CFR, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance

Preferred

• ASQ certification (CQT, CQI or similar)
• Experience with ERP/MRP systems such as NetSuite
• Experience with eQMS software such as Grand Avenue

Knowledge & Skills

• Working knowledge of quality inspection, testing, nonconformance, and product return processes
• Knowledge of QMS and regulatory requirements, including 21 CFR 820, ISO 13485, and Good Documentation Practices
• Ability to lead, coach, and prioritize daily work for inspectors and technicians
• Strong analytical, problem-solving, and data trending skills using Excel and quality metrics
• Effective communication and collaboration skills with a continuous improvement mindset

Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions. Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.

US Pay Range

$61,500 - $86,205 USD