Overview
Quality Control Supervisor Jobs in Stafford Springs, CT at Hobbs Medical, Inc.
Title: Quality Control Supervisor
Company: Hobbs Medical, Inc.
Location: Stafford Springs, CT
JOB FUNCTION(S):
Responsible for overseeing daily quality control (QC) operations, ensuring that medical device products comply with FDA, ISO 13485, and GMP standards. This role supervises QC technicians, coordinates inspections, and supports continuous improvement initiatives to maintain high product quality.
EDUCATIONAL & PROFESSIONAL REQUIREMENTS:
·        Minimum requirement: two (2) year degree in engineering or a like science and equivalent experience as a quality professional in a manufacturing setting; preferably medical device
·        Prior experience with plastics/ injection molding
·        Familiarity with and ability to interpret regulatory requirements and directives pertaining to medical devices
·        Understanding of FDA and ISO criteria
·        Excellent written and verbal communication skills
·        Proficiency with use of inspection tools and methods
·        Experience using MS Excel a plus
·        Experience using medical device labeling software/printers a plus
·        Experience using ERP software a plus
RESPONSIBILITIES:
·        Serve as a functional lead of the Quality Control department.
·        Train QC staff in inspection procedures and techniques.
·        Oversee incoming, in-process, and final inspections of raw materials, components, and finished products.
·        Ensure compliance with FDA 21 CFR Part 820, FDA 21 CFR Part 830, ISO 13485, and Good Manufacturing Practices (GMP).
·        Review printed medical device labels.
·        Coordinate calibration of monitoring and measuring equipment in accordance with the calibration schedule.
·        Maintain inspection records, test reports, and quality documentation in compliance with regulatory standards.
·        Collaborate with Engineering and Production teams to identify quality issues and process inefficiencies, recommending corrective actions to improve inspection methods and manufacturing process controls.
·        Support Quality Assurance in performing non-conformance (NC) investigations and corrective/preventive action (CAPA) processes including root cause analysis.
·        Assist Quality Assurance with collection and analysis of QC data for Management Review.
·        Assist with other QC Department functions as required
