Document Control Coordinator
About this role
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.
Company at a glance
American Manufacturing, Serving the World
We are driven by precision. Our engineering expertise and precision-machining capabilities serve the medical, aerospace and defense, and industrial markets. We offer a synergy of resources to reduce your manufacturing costs, optimize the performance of your components and products, and cut your supply chain risks.
ARCH has multiple state-of-the-art facilities that manufacture high-quality cutting tools, precision-machined components, and products. Working with ARCH, your business gains the advantage of an expanding range of cutting-edge resources for all your precision-machining needs. Our facilities are strategically located across the U.S. to optimize your outsourced precision-machining needs.
We strive to be your trusted and proactive partner. ARCH is structured to provide the capacity, flexibility, and scalability you need to succeed. We offer design-for-manufacturability, prototyping, on-site application testing, program management, technical support, and customized services.
The rise of American manufacturing requires the support of highly evolved and collaborative precision-machining partners. Our comprehensive experience in critical part production across a broad range of applications allows us to provide a dynamic range of solutions.
We truly understand the critical nature of the components and products we work with and are intently focused on delivering exacting quality to our customers, and ultimately to their customers. We combine leading-edge expertise and industry standards to ensure consistent quality at every step.
To maintain our leading edge, we invest in the continuous improvement of our manufacturing and quality assurance processes. The sharing of knowledge, technologies, and best practices across our teams strengthens our competitive advantage, accounting for performance breakthroughs, value creation, and cost containment.
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