Quality Assurance Specialist
10 hours ago
Barton Staffing Solutions is seeking an experienced Quality Assurance Specialist to join their team. As a key member of the quality team, you will be responsible for ensuring the effective implementation of Quality Management Systems (QMS) and leading continuous improvement initiatives.
Key Responsibilities- Liaise with the Quality Manager to support Quality System initiatives, including Change Control, CAPA, Complaints, and Internal/External Audits.
- Lead continuous improvement initiatives to ensure the QMS is implemented effectively by trending data and using metrics to analyze performance.
- Support the Change Control Program by assessing Quality Assurance tasks and impacts of operational and product changes.
- Provide guidance to junior level Specialists on complex issues, assist with onboarding trainings, and review the work of Specialists prior to delivery to a manager.
- Provide guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.
- Research part numbers, drawings, ECOs, etc. as requested/required.
- Research problems related to controlled documents by using available resources, including current masters, obsolete masters, engineering card files, ECO binder, computer ECO Log, Master Document Distribution List, etc.
- Create or assist document owners in creating Document Change Requests (DCR) and/or Engineering Change Orders (ECO) and the associated file.
- Execute implementation actions as required for DCR and ECOs.
- Close DCR and ECOs after verifying that they are complete.
- Compare redlines to complete engineering drawings, BOMs, literature, and other documents for accuracy.
- Assist in preparing and executing external audits as required.
- Perform other tasks as assigned.
- Experience working in regulated environments and knowledge of applicable regulations/standards including 21CFR820, ISO 13485, cGMPs, FDA Guidelines.
- Ability to read engineering drawings.
- Ability to use available resources to track document history and to research problems.
- Excellent written English skills.
- Good computer skills. Ability to use Word, Excel, and MS Outlook.
- Excellent attention to detail.
- Excellent skills in organization.
- Ability to travel internationally.
- B.A. Degree in a related field, or equivalent work experience, preferred.
- 8 years of experience, preferred.
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