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Key Responsibilities and Required Skills for Quality Systems Supervisor

💰 $ - $

Quality AssuranceQuality SystemsComplianceManufacturingRegulatory

🎯 Role Definition

The Quality Systems Supervisor is responsible for managing and maintaining the organization’s Quality Management System (QMS) to ensure compliance with internal standards, customer requirements, and regulatory frameworks. This role supervises quality system activities, leads audits, manages documentation, and partners with cross-functional teams to drive quality, compliance, and continuous improvement across operations.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Quality Engineer or Quality Analyst
  • Quality Assurance Specialist
  • Document Control or Compliance Coordinator

Advancement To:

  • Quality Manager
  • Senior Quality Systems Manager
  • Director of Quality or Compliance

Lateral Moves:

  • Regulatory Affairs Manager
  • Continuous Improvement or Process Excellence Manager

Core Responsibilities

Primary Functions

  • Oversee the development, implementation, and maintenance of the Quality Management System (QMS).
  • Ensure compliance with applicable standards such as ISO 9001, ISO 13485, IATF 16949, FDA, or GMP requirements.
  • Supervise quality systems staff, providing training, coaching, and performance feedback.
  • Lead internal audits, coordinate external audits, and ensure timely closure of audit findings.
  • Manage document control processes, including SOPs, work instructions, and quality records.
  • Review and approve controlled documents to ensure accuracy, consistency, and compliance.
  • Oversee corrective and preventive action (CAPA) processes, including root cause analysis and effectiveness checks.
  • Monitor and report key quality metrics and system performance indicators.
  • Support change management activities by assessing quality system impacts and ensuring proper documentation updates.
  • Ensure effective management of nonconformances, deviations, and customer complaints.
  • Partner with manufacturing, engineering, and supply chain teams to resolve quality system issues.
  • Ensure training programs meet regulatory and internal requirements, including training record maintenance.
  • Coordinate management review meetings and prepare quality system performance reports.
  • Maintain inspection readiness for regulatory and customer audits.
  • Drive continuous improvement initiatives related to quality systems and compliance processes.
  • Ensure supplier quality system compliance through audits, assessments, and documentation review.
  • Interpret and communicate regulatory and standard updates to relevant stakeholders.
  • Support validation activities and quality system elements related to process changes.
  • Manage electronic quality management systems (eQMS) and ensure data integrity.
  • Promote a culture of quality, compliance, and accountability across the organization.

Secondary Functions

  • Assist with quality risk assessments and mitigation planning.
  • Support cross-functional quality improvement projects.
  • Contribute to the development of quality policies and strategic objectives.
  • Provide quality system expertise during new product or process introductions.

Required Skills & Competencies

Hard Skills (Technical)

  • Strong knowledge of Quality Management Systems (QMS)
  • Experience with ISO, FDA, GMP, or IATF regulatory standards
  • Internal and external audit leadership experience
  • Corrective and Preventive Action (CAPA) management
  • Document control and records management expertise
  • Root cause analysis methodologies (e.g., 5 Whys, Fishbone)
  • Quality metrics and reporting
  • Experience with electronic QMS platforms
  • Change management and validation support
  • Supplier quality system oversight

Soft Skills

  • Strong leadership and team supervision skills
  • Excellent attention to detail and organizational skills
  • Clear written and verbal communication abilities
  • Ability to influence cross-functional teams
  • Problem-solving and critical thinking skills
  • Ability to manage multiple priorities and deadlines
  • Professional judgment and decision-making
  • Coaching and mentoring capabilities
  • Adaptability in regulated environments
  • Commitment to continuous improvement and compliance

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree or equivalent experience

Preferred Education:

  • Bachelor’s degree in Engineering, Quality, or a related field

Relevant Fields of Study:

  • Quality Assurance or Quality Management
  • Engineering or Industrial Technology

Experience Requirements

Typical Experience Range:

  • 5–8 years of experience in quality systems or quality assurance roles

Preferred:

  • Prior supervisory or leadership experience in regulated manufacturing environments
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