Change Requests/Orders, Code of Federal Regulations, Corrective Action, Data Entry, Design Document, Detail Oriented, Document Control, Document Management, Documentation, External Audit, FDA (Food and Drug Administration), Filing System Design, ISO (International Organization for Standardization), Internal Audit, Manufacturing, Medical Equipment, Organizational Skills, Quality Assurance Methodology, Quality Control, Quality Management, Record Keeping, Regulations, Staff Training, Support Documentation, Trend Analysis, Typing
Primary Responsibilities
- Maintains, updates and manages QCBD (Quality Collaboration By Design) document file system.
- Organizes and oversees QCBD training related to the Quality Management system.
- Executes document approval, release, archival, and obsolescence, per the quality system.
- Modifies and documents changes to Quality System Procedures.
- Functions as an information source for production, and other departments when critical quality documentation issues arise.
- Submits and processes change orders under ISO 13485 and FDA 21 CFR Part 820.
- Monitors device history records process to meet ISO 13485 and FDA 21 CFR Part 820.
- Performs device history record review.
- May perform data entry and trend analysis and initiate negative trend corrective actions.
- Works with management in all company areas to effectively resolve document errors/omissions.
- Updates and maintains product DMR's.
- Maintains staff training records and working with supervision ensuring that all QCBD training is to current requirements.
- Accurately enters data into EPICOR.
- Provides document support for internal and external audits, as needed.
- May educate and instruct plant personnel in recommended quality control testing and equipment methods and acceptable documentation practices.
- Assists other departments with ad-hoc projects and serves as a back up per business needs.
- Other duties as assigned.
Qualifications
- Associate degree in applicable technical discipline is strongly preferred or equivalent,
- or two (2) to three (3) years of experience in medical device manufacturing industry and/or document management systems and/or training,
- or equivalent combination of education and experience.
- Basic regulatory knowledge in medical regulations.
- Accuracy of typing skills and extreme attention to detail are required.
- Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.
Shifts Available: 1st shift
Salary Range: $26.00 - $30.00/hr based on experience
Equal Employer Opportunity
ARCH is an Equal Opportunity Employer who wholeheartedly supports diversity in the workplace as basic premise for business success. We do not discriminate on a basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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ARCH Medical Solutions Corp