Quality Assurance Documentation Specialist
7 days ago
Fathom Mfg, a leading digital manufacturing platform, is seeking a Quality Assurance Documentation Specialist to support the integrity of medical device data within our contract manufacturing environment.
About the RoleThis position plays a critical role in maintaining and ensuring the accuracy of key quality-related documentation, including device history records, nonconformance reports, customer complaints, and other essential records that support our Quality Management System (QMS).
The ideal candidate will possess a keen eye for detail, strong analytical skills, and proficiency in document management systems and databases.
Key Responsibilities- Document review of device history records, nonconformance reports, customer complaints, and other documents or records required to support the QMS.
- Scanning and organizing reviewed documentation in a computer database system or manual data entry as needed.
- Assist the Quality Manager and other Quality representatives in the maintenance of procedures, work instructions, forms, etc., relevant to a QMS in compliance with ISO 13485, ISO 9001, and regulatory requirements.
- Experience within a quality management system or quality assurance, preferably within the medical device manufacturing industry.
- Strong attention to detail with a focus on accuracy within documentation.
- Proficient in document management systems and databases.
- Strong analytical skills to interpret data and identify discrepancies.
- Understanding of quality control processes, nonconformance management, and root cause analysis.
- Knowledge of regulatory requirements for medical devices and experience in dealing with certified audits.
- Ability to proactively identify issues and recommend solutions to enhance quality processes.
- Strong organizational skills with the ability to manage multiple tasks and prioritize effectively in a fast-paced environment.
- Maintain a regular and predictable work schedule.
- Experience with MS Office & Adobe.
- HS Diploma or equivalent required.
We offer a competitive salary range of $45,000 - $65,000 per annum, depending on qualifications and experience, and a benefits package that includes health insurance, paid time off, and professional development opportunities.
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