Quality Systems Specialist

Quality Systems Specialist

Location:

Monroe, US, 28110

Employment Type:

Permanent

Responsibilities:

• Electronic Quality Document System (eQMS) Management:
  • Coordinate document control, including the review, approval, and maintenance of SOPs and controlled documents.
  • Collaborate with document owners to ensure efficient and compliant procedures that facilitate cross‑functional integration.
• Corrective and Preventive Actions (CAPA):
  • Initiate and coordinate use of the CAPA process, ensuring thorough investigation, root cause analysis, and timely completion of corrective actions.
  • Participate on the CAPA Review Board to discuss ongoing issues, drive timely closure, and communicate CAPA metrics to senior management.
  • Conduct and review CAPA effectiveness checks, ensuring corrective actions are adequate and sustainable.
• Change Control:
  • Initiate and coordinate change control activities, ensuring that changes are documented, evaluated for risk, and implemented in compliance with QMS.
  • Provide guidance and support for change control processes across departments to ensure consistency and effectiveness.
• Nonconformance (NCR):
  • Facilitate and lead NCR investigations involving multiple investigation areas; work with manufacturing, packaging, quality control, maintenance, engineering, and supply chain to conduct investigations, determine root cause, and implement improvements.
  • Perform investigations using structured root‑cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine the "true" root cause.
  • Analyze deviation trends and provide insights into continuous improvement initiatives.

Job Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3–5 years of experience in the medical device industry, with a strong background in QMS, CAPA, audits, and regulatory compliance (ISO 13485, 21 CFR 820).
• Experience working with an electronic Quality Management software; experience with Master Control implementation preferred.
• Strong knowledge of FDA and ISO quality standards and the ability to lead regulatory compliance initiatives.

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.

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