|Title:||Document Control Specialist|
ESSENTIAL Responsibilities Include:
- Responsible for keeping current and knowledgeable of the Company’s quality policy and applicable quality objectives; provides support to achieve objectives.
- Process ECOs in a timely manner, according to the Company’s quality system procedures.
- Oversee the quality records and logs; ensure they are retained according to the regulatory and quality system requirements.
- Responsible for improving the efficiency of Document Control while maintaining regulatory compliance for all activities that are part of Document Control.
- Prepare metrics for document control and provide periodic updates.
- Follow and enforce compliance to the Company’s quality system and regulatory body requirements per ISO 13485 and FDA 21 CFR 820 as applicable to Document and Record Control.
- Timely electronic distribution of latest revision level documentation to all appropriate users and ensure removal of obsolete documentation.
- Coordinate Change Control Board Meetings, maintaining agenda, minutes, and schedule.
- Regular attendance.
- Abide by all safety and security rules set forth by the company and regulatory agencies.
- Associates degree in business is preferred.
- Previous Document Control is strongly preferred
- Strong knowledge of FDA’s QSRs, ISO 13485:2016 related to document and record control.
- Experience as a change analyst desired.
- Excellent organizational skills with high level of detail orientation.
- Ability to work well under pressure, to handle multiple tasks, and to meet aggressive deadlines.
- Experience reading and understanding regulations, standards, drawings and procedures.
- Proficient computer skills with documentation related databases and Microsoft Office (Word and Excel).
Biomedical Innovations is an Equal Opportunity Employer; and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Biomedical Innovations will provide reasonable accommodations for qualified individuals with disabilities.If you need assistance with completing the online application process, please call Biomedical Innovations at (208) 263-5071.