What are the responsibilities and job description for the Quality Systems Specialist position at Greiner?
Quality Systems Specialist
Location:
Monroe, US, 28110
Travel activity: N/a
Employment Type: Permanent
Your challenge
Responsibility:
The Quality System Specialist is responsible for working within the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality. This role focuses on performing activities within the electronic quality document system (eQMS), Corrective and Preventive Actions (CAPAs), change control processes, and audit programs.
o Collaborate with document owners to ensure efficient and compliant procedures that facilitate cross-functional integration.
o Participate on the CAPA Review Board to discuss ongoing issues, drive timely closure, and communicate CAPA metrics to senior management.
o Conduct and review CAPA effectiveness checks, ensuring corrective actions are adequate and sustainable.
o Provide guidance and support for change control processes across departments to ensure consistency and effectiveness.
o Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause.
o Analyze deviation trends and provide insights into continuous improvement initiatives.
The Quality System Specialist is responsible for working within the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality. This role focuses on performing activities within the electronic quality document system (eQMS), Corrective and Preventive Actions (CAPAs), change control processes, and audit programs.
- Electronic Quality Document System (eQMS) Management:
o Collaborate with document owners to ensure efficient and compliant procedures that facilitate cross-functional integration.
- Corrective and Preventive Actions (CAPA):
o Participate on the CAPA Review Board to discuss ongoing issues, drive timely closure, and communicate CAPA metrics to senior management.
o Conduct and review CAPA effectiveness checks, ensuring corrective actions are adequate and sustainable.
- Change Control:
o Provide guidance and support for change control processes across departments to ensure consistency and effectiveness.
- Nonconformance (NCR):
o Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause.
o Analyze deviation trends and provide insights into continuous improvement initiatives.
Your Profile
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 in with an electronic Quality Management software. Experience with implementation MasterControl 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.
Job ID: 3683