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Linde Gas & Equipment Inc. is seeking a Quality Assurance Specialist to join our team located in Los Angeles, CA.
The Quality Assurance Specialist will be responsible for reviewing and ensuring all steps in the manufacturing, testing, storage and distribution process for medical products at the Bethlehem Facility and are performed in accordance with FDA's applicable regulations and LINDE's standard operating procedures. The Quality Assurance Specialist will handle the quality oversight and auditing of production and incoming inspection activities, review of change requests, and investigation of non-conformances and out of specification reports. The Quality Assurance Specialist will have the ability to work independently and to provide consultative advice within specific areas of expertise.
Quality Assurance Specialist
- Reviews all steps performed and ensures that the step in the manufacturing process has taken place as defined in the Batch Production Record.
- Reports findings of in-process errors and provides follow-up to ensure adequate completion of corrective actions.
- Performs and coordinates quality investigations with appropriate levels of corrective/preventive actions and closes in a timely manner.
- Supports product quality complaint investigations, assisting in data processing of Adverse Events and appropriate reporting for U.S. and Canada complaints. Supports the receipt/review of product complaint samples. Participates in the investigation and resolution of non-conformances of all types.
- Quality review of System Preventative Maintenance activities.
- Support initiatives in Continuous Quality Improvement.
- Provides training in GMP and quality principles to personnel in all departments when assigned. Assists in maintenance of training schedules and training records systems.
- Assists in the review and approval of Change Controls.
- Assists in internal and supplier audits and establishing/updating supplier and component specifications and testing as needed.
- Assists with tracking and trending of deviations and complaints.
- Follows all safety rules/regulations and immediately reports infractions and/or workplace injuries/accidents to proper personnel.
- Ensures for product disposition, e.g., approvals for release, distribution or rejection.
- Ensures labels are appropriately reviewed and approved for use and meet all internal and external requirements
- Other duties as assigned
- Bachelor's/Associates Degree in a Science/ Engineering or related technical field
- Background in quality medical products preferred
- Knowledge in the FDA's regulations for medical products 21 CFR part 210 and 211
- Strong communication skills & organizational agility
- Solid organizational skills
- Strong knowledge of Microsoft Office Applications and Lotus Notes database skillsets
- ISO 9001 or ISO 13485 and or regulatory experience
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, protected veteran status, pregnancy, sexual orientation, gender identity or expression, or any other reason prohibited by applicable law.
This job has expired.