Greiner Bio-One Americas
Quality System Specialist – Greiner Bio-One Americas
Join the Greiner Bio-One Americas team as a Quality System Specialist to maintain product quality and regulatory compliance within the medical device industry.
Responsibilities
Manage the electronic quality document system (eQMS): review, approve, and maintain SOPs and controlled documents.
Coordinate document control and collaborate with document owners to ensure efficient, compliant procedures across functions.
Lead the CAPA process: initiate, investigate root causes, coordinate corrective actions, and participate on the CAPA Review Board to close issues and report metrics.
Conduct CAPA effectiveness checks to confirm corrective actions are adequate and sustainable.
Initiate change control activities: document, evaluate risk, and implement changes in compliance with QMS.
Guide and support change control processes across departments for consistency and effectiveness.
Lead NCR investigations across multiple departments, perform structured root cause analysis (fishbone, 5 Why’s), determine true root cause, and implement improvements.
Analyze deviation trends and provide insights into continuous improvement initiatives.
Qualifications
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 with an electronic Quality Management software; MasterControl implementation preferred.
Strong knowledge of FDA and ISO quality standards, and ability to lead regulatory compliance initiatives.
We provide equal opportunities for everyone and see diversity as our strength. We welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have 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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Responsibilities
Manage the electronic quality document system (eQMS): review, approve, and maintain SOPs and controlled documents.
Coordinate document control and collaborate with document owners to ensure efficient, compliant procedures across functions.
Lead the CAPA process: initiate, investigate root causes, coordinate corrective actions, and participate on the CAPA Review Board to close issues and report metrics.
Conduct CAPA effectiveness checks to confirm corrective actions are adequate and sustainable.
Initiate change control activities: document, evaluate risk, and implement changes in compliance with QMS.
Guide and support change control processes across departments for consistency and effectiveness.
Lead NCR investigations across multiple departments, perform structured root cause analysis (fishbone, 5 Why’s), determine true root cause, and implement improvements.
Analyze deviation trends and provide insights into continuous improvement initiatives.
Qualifications
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 with an electronic Quality Management software; MasterControl implementation preferred.
Strong knowledge of FDA and ISO quality standards, and ability to lead regulatory compliance initiatives.
We provide equal opportunities for everyone and see diversity as our strength. We welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have 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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