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Key Responsibilities and Required Skills for Quality Systems Specialist

💰 $75,000 - $115,000

Quality AssuranceComplianceManufacturingMedical DevicesPharmaceuticalsAerospace

🎯 Role Definition

The Quality Systems Specialist is a pivotal role dedicated to the development, implementation, and continuous improvement of the organization's Quality Management System (QMS). This individual acts as a subject matter expert on quality standards (such as ISO 9001, ISO 13485, and 21 CFR 820) and serves as a key liaison during internal and external audits. You will be responsible for managing critical quality processes including document control, CAPA, non-conformances, and training, ensuring the organization consistently meets and exceeds customer and regulatory requirements. This position requires a blend of technical expertise, analytical prowess, and strong collaborative skills to foster a robust culture of quality throughout all business functions.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Quality Technician / Inspector
  • Documentation Control Coordinator
  • Junior Quality Engineer

Advancement To:

  • Senior Quality Systems Specialist
  • Quality Assurance Manager
  • Director of Quality / Compliance

Lateral Moves:

  • Quality Engineer
  • Regulatory Affairs Specialist
  • Supplier Quality Engineer

Core Responsibilities

Primary Functions

  • Develop, implement, and maintain the Quality Management System (QMS) in full compliance with applicable standards such as ISO 13485, ISO 9001, and/or FDA 21 CFR Part 820.
  • Manage the entire lifecycle of controlled documents, including the creation, review, approval, distribution, and obsolescence of SOPs, work instructions, and quality manuals within the electronic document management system (eDMS).
  • Lead and meticulously manage the Corrective and Preventive Action (CAPA) program, from initiation and investigation to conducting root cause analysis, implementing robust solutions, and verifying effectiveness.
  • Administer the Non-conformance (NCR) process, ensuring timely and thorough evaluation, segregation of non-conforming product, and disposition of materials.
  • Plan, schedule, and execute internal audits to assess the health and compliance of the QMS, documenting findings and tracking corrective actions through to closure.
  • Act as a primary point of contact and subject matter expert during external audits and regulatory inspections (e.g., FDA, Notified Body, customer audits), preparing documentation and coordinating responses.
  • Oversee the employee training program related to the QMS, including developing training materials, conducting sessions, and maintaining comprehensive training records.
  • Facilitate and prepare for Management Review meetings by compiling quality performance data, generating reports on key performance indicators (KPIs), and tracking action items.
  • Manage the supplier qualification and monitoring process, including conducting supplier audits, maintaining the Approved Supplier List (ASL), and tracking supplier performance.
  • Support design and development projects by providing quality systems expertise, participating in design reviews, and ensuring design control documentation meets regulatory requirements.
  • Administer the change control process, ensuring all changes to products, processes, and the QMS are properly documented, evaluated for risk, and approved prior to implementation.
  • Drive continuous improvement initiatives by analyzing quality data, identifying trends, and championing projects to enhance process efficiency and product quality.
  • Manage the calibration and preventive maintenance program for all measurement and test equipment, ensuring all devices are maintained in a state of control.
  • Investigate and document customer complaints, collaborating with cross-functional teams to determine root cause and implement effective corrective actions to enhance customer satisfaction.
  • Maintain and update key quality system logs and records, including CAPA, NCR, Complaint, Audit, and Training logs, ensuring they are always audit-ready.
  • Provide guidance and interpretation of quality regulations, standards, and internal procedures to personnel across all departments to ensure consistent application.
  • Develop and report on quality metrics and trends to senior management, providing actionable insights derived from data analysis of quality system elements.
  • Lead and participate in risk management activities (e.g., FMEA, Hazard Analysis) in accordance with ISO 14971 or other relevant standards.
  • Author, review, and approve validation and verification protocols and reports for processes, equipment, and software to ensure they meet specified requirements.
  • Serve as the administrator for the electronic Quality Management System (eQMS), managing user access, system configuration, and providing support to all users.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis to investigate quality trends and support departmental inquiries.
  • Contribute to the organization's broader continuous improvement and operational excellence strategy and roadmap.
  • Collaborate with business units, including R&D, Manufacturing, and Supply Chain, to translate quality needs into actionable system and process requirements.
  • Participate in sprint planning and agile ceremonies for projects related to the implementation or enhancement of quality software systems.

Required Skills & Competencies

Hard Skills (Technical)

  • QMS Standards Expertise: In-depth knowledge and practical application of quality standards such as ISO 9001, ISO 13485, FDA 21 CFR Part 820, AS9100.
  • Audit Management: Certified Lead Auditor (e.g., ISO 13485) with proven experience leading internal audits and supporting external regulatory inspections.
  • CAPA and Root Cause Analysis: Proficiency in systematic problem-solving methodologies including 5 Whys, Fishbone (Ishikawa) diagrams, and Failure Mode and Effects Analysis (FMEA).
  • Document Control Management: Expertise in managing the full lifecycle of controlled documents and records, preferably within an electronic system.
  • eQMS Software Proficiency: Hands-on experience with electronic Quality Management Systems such as MasterControl, Veeva QualityDocs, TrackWise, or similar platforms.
  • Risk Management: Knowledge of risk management principles and tools as defined by ISO 14971 or equivalent industry standards.
  • Statistical Analysis: Competency in using statistical tools (e.g., Minitab) for process control (SPC), data analysis, and trending of quality metrics.
  • Technical Writing: Ability to author clear, concise, and compliant technical documents, including procedures, work instructions, and investigation reports.

Soft Skills

  • Meticulous Attention to Detail: An unwavering commitment to accuracy and precision in all tasks, especially concerning documentation and compliance.
  • Analytical and Problem-Solving Skills: Strong ability to analyze complex issues, identify root causes, and develop effective, sustainable solutions.
  • Cross-Functional Collaboration: Proven ability to work effectively with diverse teams (Engineering, R&D, Operations) to achieve common quality goals.
  • Communication and Interpersonal Skills: Excellent written and verbal communication skills, with the ability to train others and articulate complex concepts clearly to various audiences.
  • Project Management and Organization: Superior organizational skills with the capacity to manage multiple priorities, projects, and deadlines simultaneously.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in a relevant field.

Preferred Education:

  • Bachelor's or Master's degree in an engineering or scientific discipline.
  • Quality-related certifications (e.g., ASQ CQE, CQA).

Relevant Fields of Study:

  • Engineering (Biomedical, Industrial, Mechanical)
  • Life Sciences (Biology, Chemistry, Microbiology)
  • Quality Management

Experience Requirements

Typical Experience Range: 3-7 years of direct experience within a Quality Systems or Quality Assurance role in a regulated industry.

Preferred:

  • Direct experience in the medical device, pharmaceutical, or biotechnology industry.
  • Proven track record of successfully managing or hosting regulatory audits (e.g., FDA, Notified Body).
  • Demonstrable experience driving continuous improvement projects that resulted in measurable gains in compliance and efficiency.
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