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Key Responsibilities and Required Skills for a Quality Systems Manager

💰 $110,000 - $165,000

Quality AssuranceManagementManufacturingComplianceEngineering

🎯 Role Definition

The Quality Systems Manager is the strategic leader and primary custodian of the organization's Quality Management System (QMS). This individual architects, implements, and continuously improves the quality framework to ensure products and processes consistently meet customer expectations and regulatory requirements. This role acts as the central hub for compliance, bridging the gap between operational teams, senior leadership, and external regulatory bodies. The Quality Systems Manager champions a culture of quality, driving systemic improvements that enhance efficiency, reduce risk, and support the company's strategic objectives.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Senior Quality Engineer
  • Compliance Specialist / Manager
  • Supplier Quality Manager
  • Manufacturing or Process Engineer with a strong quality focus

Advancement To:

  • Director of Quality Assurance
  • Senior Director of Global Quality & Compliance
  • Vice President of Operations / Quality

Lateral Moves:

  • Operations Manager
  • Regulatory Affairs Manager
  • Continuous Improvement Manager

Core Responsibilities

Primary Functions

  • Architect, implement, and maintain the company's Quality Management System (QMS) to ensure full compliance with applicable standards such as ISO 9001, ISO 13485, IATF 16949, or AS9100.
  • Serve as the primary subject matter expert and point of contact during external audits from regulatory agencies (e.g., FDA, Notified Bodies) and key customers.
  • Lead and manage the entire internal audit program, from planning and scheduling to execution, reporting, and verification of corrective actions to ensure ongoing system effectiveness.
  • Oversee and enhance the Corrective and Preventive Action (CAPA) program, ensuring timely and effective root cause analysis, action implementation, and verification of effectiveness.
  • Manage the document control and records management system, guaranteeing that all procedures, work instructions, and records are current, controlled, and readily accessible.
  • Host and prepare for Management Review meetings, compiling and presenting data on QMS performance, including key performance indicators, trends, and strategic improvement opportunities.
  • Drive a culture of continuous improvement by utilizing methodologies like Lean, Six Sigma, and Kaizen to identify and eliminate process inefficiencies and quality issues.
  • Direct the nonconforming material control process, including the Material Review Board (MRB), ensuring proper segregation, disposition, and documentation of non-compliant products.
  • Manage the supplier quality management program, including supplier evaluation, qualification, auditing, and performance monitoring to ensure a robust and compliant supply chain.
  • Develop, track, and report on key quality metrics and KPIs to senior leadership, providing clear insights into the health of the QMS and identifying areas for strategic focus.
  • Lead and manage the change control process, ensuring that all changes to products, processes, and the QMS are properly documented, evaluated for risk, and approved before implementation.
  • Oversee the employee training program related to the QMS, ensuring all personnel are adequately trained on quality policies, procedures, and their specific responsibilities.
  • Act as the QMS software administrator (e.g., for platforms like Veeva, TrackWise, or MasterControl), managing system configurations, user access, and validation activities.
  • Facilitate risk management activities across the organization, applying tools like FMEA (Failure Mode and Effects Analysis) to proactively identify and mitigate potential quality and compliance risks.
  • Ensure data integrity principles are embedded within all quality system processes and electronic records, maintaining the accuracy and reliability of all quality-related data.
  • Provide quality systems support for New Product Introduction (NPI) projects, ensuring design controls and other quality requirements are met throughout the development lifecycle.
  • Develop and manage the departmental budget for the quality systems function, ensuring efficient allocation of resources to meet compliance and improvement goals.
  • Mentor, coach, and develop a team of quality specialists and engineers, fostering a high-performance environment and building quality competency within the organization.
  • Investigate and respond to complex customer complaints, ensuring thorough investigation, root cause analysis, and effective communication back to the customer.
  • Stay abreast of evolving international standards, regulations, and industry best practices, and proactively update the QMS to maintain a state of continuous compliance and audit readiness.

Secondary Functions

  • Support and participate in cross-functional continuous improvement projects and events.
  • Develop and deliver quality systems and compliance-focused training to all levels of the organization.
  • Collaborate with IT and other departments to validate and implement new software or systems that impact the QMS.
  • Assist the Regulatory Affairs team by providing necessary QMS documentation and data for regulatory submissions.

Required Skills & Competencies

Hard Skills (Technical)

  • Expertise in QMS Standards: In-depth, practical knowledge of international quality standards (e.g., ISO 9001, ISO 13485, FDA 21 CFR Part 820, AS9100).
  • Audit Management: Certified Lead Auditor (e.g., ISO 9001 or 13485) with extensive experience leading internal and external audits.
  • CAPA and Root Cause Analysis: Mastery of structured problem-solving methodologies such as 8D, 5 Whys, Fishbone Diagrams, and Fault Tree Analysis.
  • Risk Management: Proficiency in risk management tools and standards, particularly ISO 14971 for medical devices or FMEA.
  • Statistical Process Control (SPC): Ability to apply statistical methods to monitor and control processes, including experience with software like Minitab.
  • Document Control Systems: Hands-on experience managing electronic document control and eQMS platforms (e.g., MasterControl, Veeva Vault Quality, TrackWise Digital).
  • Validation Principles: Strong understanding of process validation (IQ, OQ, PQ) and Computer System Validation (CSV) requirements.
  • Supplier Quality Management: Experience in conducting supplier audits, developing supplier scorecards, and managing SCARs (Supplier Corrective Action Requests).
  • Regulatory Compliance: Deep understanding of the regulatory landscape relevant to the specific industry (e.g., medical device, pharmaceutical, aerospace).
  • Continuous Improvement Methodologies: Certification or strong practical experience in Lean Manufacturing and/or Six Sigma (e.g., Green or Black Belt).

Soft Skills

  • Leadership and Influence: Ability to lead a team and influence cross-functional peers and senior management to drive a culture of quality.
  • Exceptional Communication: Articulate and clear written and verbal communication skills, capable of presenting complex information to diverse audiences.
  • Analytical and Strategic Thinking: Strong capability to analyze complex data, identify trends, and develop long-term strategies for quality system improvement.
  • Meticulous Attention to Detail: An unwavering focus on accuracy and thoroughness in all aspects of QMS management and documentation.
  • Project Management: Proven ability to manage multiple complex projects simultaneously, from planning to successful completion.
  • Problem-Solving: A tenacious and methodical approach to identifying and resolving complex systemic issues.
  • Collaboration and Teamwork: A natural ability to build strong working relationships across all functions and levels of the organization.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's of Science (B.S.) degree.

Preferred Education:

  • Master's of Science (M.S.) or Master's in Business Administration (MBA).
  • Professional certifications such as ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), or Six Sigma Black Belt.

Relevant Fields of Study:

  • Engineering (Industrial, Mechanical, Biomedical)
  • Life Sciences (Biology, Chemistry)
  • Business Administration or Management

Experience Requirements

Typical Experience Range: 7-12 years of progressive experience within a quality assurance function, with at least 3-5 years in a leadership or management capacity overseeing quality systems.

Preferred: Experience in a highly regulated industry such as medical devices, pharmaceuticals, biotechnology, automotive, or aerospace is strongly preferred. Demonstrable track record of successfully hosting regulatory audits (e.g., FDA, Notified Body) and driving significant QMS improvements.

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