Quality Systems Specialist

4 days ago

Vernon Hills, United States Lorenz Engineering, a division of The Salem Group Full time

Job Title: Quality Systems Specialist

Reports to: Regulatory Affairs Manager

Department: Regulatory and Quality Assurance

Position Overview:

The Quality Systems Specialist is responsible for the continuous improvement of Corrective and Preventive Actions (CAPA), internal audits, and Quality Management System (QMS) review processes. This role ensures compliance with regulatory requirements, industry standards, and internal policies to maintain and improve the company's quality management practices.

Key Responsibilities:

  • CAPA Process Improvement: Continuously improve and maintain the overall CAPA process, facilitating its implementation and leading the CAPA review board.
  • CAPA Investigations: Lead CAPA investigations, coordinating the necessary resources to determine root causes, implement corrective actions, and verify the effectiveness of these actions.
  • Collaboration: Work closely with cross-functional teams to support quality initiatives and continuous improvement efforts.
  • QMS Implementation: Oversee the effective implementation and maintenance of the Quality Management System across the organization.
  • Regulatory Compliance: Ensure the QMS complies with customer requirements, regulatory standards (e.g., RWMIC), and internal policies.
  • Quality Manual Maintenance: Regularly update and maintain the Quality Manual to ensure its contents remain relevant and accurate.
  • Policy Development: Develop, implement, and monitor quality policies, procedures, and work instructions to align with organizational needs.
  • Procedural Analysis: Analyze current and future procedural needs of the company to ensure they are met by the quality systems.
  • Internal Audits: Organize and manage the internal audit system, ensuring the corrective action reporting system is audited effectively. Conduct and lead internal QMS audits as required.
  • Management Review: Gather data and assist in conducting Management Review meetings to assess the effectiveness of the QMS.
  • Subject Matter Expert (SME): Serve as a mentor and subject matter expert in Quality Management Systems, offering support across the organization.
  • Training Development: Design and deliver in-house training programs, including QSR (Quality System Regulations) and ISO 13485 standards.
  • Regulatory Interface: Act as the primary interface with ISO registrars and secondary interface with external regulatory agencies.
  • Third-Party Audits: Coordinate third-party audits to review divisional systems and processes, ensuring compliance with CFR 820 and ISO 13485 standards.
  • Data Monitoring & Reporting: Monitor and report on quality data, focusing on CAPA and internal audit processes to ensure continuous improvement.
  • Risk Assessment: Ensure risk assessment activities are executed and maintained according to regulatory standards.

Requirements:

  • Education: Bachelor’s degree in a related field (e.g., Engineering, Quality Assurance, Life Sciences).
  • Experience: 3+ years of experience in quality systems, CAPA management, or regulatory affairs within a regulated industry, preferably medical devices.
  • Certifications: ISO 13485, QMS, or CAPA certification is a plus.
  • Skills:
  • Strong knowledge of regulatory requirements (FDA, ISO 13485, CFR 820).
  • Excellent problem-solving and analytical skills.
  • Experience with internal audits and CAPA investigations.
  • Proficiency in developing and implementing quality management systems and procedures.
  • Strong communication and interpersonal skills.
  • Ability to collaborate with cross-functional teams and lead initiatives.
  • Experience with risk assessment and mitigation strategies.



EEO

Lorenz Engineering provides equal employment opportunity to all qualified employees and applicants for employment without regard to race, color, ancestry, national origin, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other category protected by law.

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