Quality Systems Engineer

Quality Systems Engineer
Empresa:

General Electric / Critikon De Mexico


Lugar:

Chihuahua


Área:

Otros

Quality Systems Engineer

Detalles de la oferta

Requirements:
Very strong knowledge and expertise in international GMP regulations and guidelines especially in US / EU for medical devices.
Candidate must be a self-starter with excellent communication, organization, documentation skills
Quality experience in a cGMP environment for 4 or more years
Experience as a GMP auditor for 3 or more years
Experience in international regulatory inspection management incl USFDA

Responsibilities:
Develop audit plans/agendas for corporate GMP compliance assessments/audits based on risk taking into account current regulatory focus and business needs.
Execute GMP compliance audits/assessments
Produce timely, detailed and technically correct reports following assessments/audits
Communicate identified deficiencies and compliance risks to appropriate business, operations and quality heads
Advise and support the sites in devising and executing remediation actions to ensure compliance to regulatory and expectations and requirements. Approve proposed CAPA/ remediation plans, regularly review progress & effectiveness, and continue to give ongoing support in all compliance matters
Provide advice, guidance and support to sites for external audits, as requested.
Conduct pre-approval/pre-submission project reviews (e.g. products, facilities), “mock” inspections as part of the Global GMP Compliance Assessment program. Provide guidance for timely remediation.
Advise, guide and support sites in the overall regulatory inspection management.
Perform regular analysis of regulatory observations made at sites, prepare and coordinate the global follow-up/gap analysis to prevent re-occurrence and provide advice
Participate in the continuous improvement and maintenance of Quality System and Compliance risks
Participate and lead agreed Quality/Compliance projects, aligned with the company strategy and group objectives.
Develop Quality standards and processes based on expertise and assigned areas

Qualifications
Bachelor’s degree and 4 years working experience in Quality Engineering or Quality Assurance Management.
Understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.


Fuente: Empleos Maquila


Área:

Requisitos


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