Sr. Supervisor, Quality Assurance

Job Description

Job Description

Overview

The Senior Supervisor, Quality Assurance provides leadership and oversight to a Quality Assurance team for Fillauer Coapt, Point Designs, or another Hanger Products & Services entity, ensuring products and processes meet regulatory, customer, and organizational standards. This role develops and maintains quality system policies, procedures, and systems compliant with the regulatory requirements of the entity’s product lines, manages quality operations, leads root-cause investigations, drives continuous improvement initiatives, and supports compliance with internal and external audit requirements.

Responsibilities

• Provide day‑to‑day leadership, coaching, and performance management for the QA team, ensuring efficient workflow, adherence to standards, and continuous skill development.
• Oversee quality inspection, testing, and documentation processes to ensure products meet regulatory, customer, and company standards.
• Lead complex nonconformance investigations, perform root-cause analysis, and drive corrective and preventive actions that eliminate systemic issues.
• Review, approve, and maintain quality documentation such as inspection records, test results, deviations, change controls, and product release decisions.
• Coordinate and support internal audits, customer audits, and regulatory inspections; ensure prompt and accurate responses to findings.
• Analyze quality performance metrics and trends, presenting insights and actionable recommendations to leadership.
• Partner with Operations, Engineering, Supply Chain, and production leadership to resolve quality issues and improve manufacturing processes.
• Ensure the proper implementation and maintenance of quality system requirements (ISO, FDA, or industry‑specific standards).
• Lead or support validation activities, including equipment qualification, process validation, and documentation updates.
• Promote a culture of quality, accountability, and continuous improvement across the organization.
• Support strategic initiatives related to quality planning, staffing needs, system improvements, and cross‑functional project execution.
• Identify trends in scrap, rework, and process deviations; recommend improvements to enhance quality and efficiency.
• Support internal audits and contribute to maintaining compliance with ISO 13485, FDA, and QMS requirements.
• In partnership with manager, develop or update inspection plans, work instructions, and standard operating procedures.

Qualifications

• Bachelor’s degree in engineering preferred.
• A minimum of five years’ experience in a leadership role in quality of a related environment or deep technical experience with Coapt technology paired with a penchant for documentation, communication, and organization.
• Strong knowledge of ISO 13485, FDA, and QMS requirements in a medical device function.
• Strong knowledge of inspection methods, sampling plans, measurement tools, and testing techniques.
• Expertise in root-cause analysis methodologies.
• Familiarity with production workflows, engineering change management, and document control processes.
• Knowledge of internal and external audit practices and requirements.
• Understanding of validation principles, risk management, and process control.