Quality Control Supervisor

Tactile Medical•New Brighton, MN

2d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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