Quality Engineer - Katalyst Healthcares & Life Sciences

• This is a Quality Assurance role focusing on record review and control, document change control, and equipment management.

• This position is a Quality Assurance role in a manufacturing group that produces components for in-vitro diagnostic assays.

• A BS in Life Science or equivalent experience is required.

• Applicants with experience in a GMP/ISO regulated environment preferred.

• Applicant should be familiar with Good Documentation Practices.

• The successful candidate will demonstrate exceptional attention to detail and professional demeanor.

• Management of document control systems, including review of documents and processing changes.

• Manage quality record archives.

• Perform final review of device history records (DHRs) at a high level of detail.

• Perform batch disposition in SAP system.

• Maintain metrics for batch records and document control systems as applicable.

• Perform review of equipment service records, including updating information in the electronic equipment management system.

• Perform review of validation documentation for successful completion and GDP.

• Support of other Quality Assurance responsibilities as needed.

Requirements:

• Experience in a regulated environment (21 CFR 820 and/or ISO 13485)

• Equipment validation and service management (CAL/PM) .

• Technical writing .

• SAP Quality Management experience .