Senior Quality Systems Specialist

Senior Quality Systems Specialist

Location:

Monroe, US, 28110

Employment Type:

Permanent

• Change Control Management:
  • Lead and facilitate change control processes, including initiation, evaluation, approval, and documentation of changes to product specifications, manufacturing processes, and controlled documents.
  • Oversee the Change Control Board (CCB) activities, ensuring thorough review and decision‑making regarding change risks, impacts, and action plans.
  • Collaborate with cross‑functional teams, including Quality, Regulatory, Manufacturing, and R&D, to ensure change controls are well documented, traceable, and compliant.
• Product and Process Changes:
  • Assess product and process change proposals to determine compliance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements.
  • Facilitate risk assessments and root cause analyses for product or process changes, ensuring controls and mitigations are in place to maintain product integrity.
  • Work closely with operations teams to implement changes and monitor post‑implementation to confirm effectiveness and stability.
• Document Control and eQMS Administration:
  • Manage and oversee document control processes within the electronic Quality Management System (eQMS), ensuring all controlled documents are current, accessible, and aligned with internal and external standards.
  • Manage document version control and maintain documentation workflows for all changes, including SOPs, technical files, and specifications.
  • Support the administration of eQMS access, authorizations, and training to ensure appropriate and secure document handling across the organization.
  • Manage the verification and implementation process of source documents from GBO Centers in cooperation with the departments in charge.
  • Manage filing of documents and records according to policies and regulatory standards.
• Training and Guidance:
  • Provide training and mentorship to team members and departments on change control procedures, risk assessment, and compliance requirements.
  • Facilitate regular workshops or refresher sessions to keep stakeholders informed of updates in change control best practices and eQMS functionalities.

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• 3+ years of experience in change control within a regulated environment, ideally in medical devices or pharmaceuticals.
• Strong knowledge of FDA QSR, ISO 13485, and cGMP requirements.
• Experience with electronic Quality Management Systems (eQMS) and document control.

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of identifying characteristics such as gender, age, background, social status, veteran status, sexual orientation, religion, or mental and physical abilities. We have additionally set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.