Quality Engineer - Elkhart, IN, 46515
Salary undisclosed
Apply on
Original
Simplified
Description
This is a Quality Assurance role focusing on record review and control, document change control, and equipment management.
Specific Requirements
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.
Key Responsibilities
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
Preferred Knowledge/Skills, Education, Experience
Support of other Quality Assurance responsibilities as needed
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
This is a Quality Assurance role focusing on record review and control, document change control, and equipment management.
Specific Requirements
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.
Key Responsibilities
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
Preferred Knowledge/Skills, Education, Experience
Support of other Quality Assurance responsibilities as needed
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
Similar Jobs
