About this role
Essential Duties and Responsibilities
- Identifying and managing all controlled documentation to ensure compliance with operational, corporate and regulatory requirements.
- Providing effective and efficient documentation and records management.
- Coordinating the scheduling of formal document reviews for site documentation.
- Maintains file system of the current drawing revisions and documents of external origins
- Communicating changes to document control procedures or other relevant information which have been updated or added.
- Disposing or destroying records and documents in a secure and proper way when retention periods expire.
- Scan and enter material certifications and SDS into the system
- Conduct Risk Assessments and Job Hazard Analysis if OSHA 10-hour certified
- Enter Equipment Risk Assessments and Job Hazard Analysis into HQMS
- Support Customer and Regulatory audits by pulling required documentation
- Prepare work orders for production team and verify that all required documentation is attached.
- Read blueprints, data, manuals, or other materials to determine specifications,
inspection, and testing procedures, adjustment methods, certification processes, or
measurement instruments required for work orders.
- Measure and document core/mandrel dimensional readings for lot release.
- Review and approve inspection results and device history records for completeness.
- Create the Certificate of Conformance and all customer requirements for shipping.
- Reading and interpreting manufacturing procedures, engineering drawings, customer specifications and inspection procedures and comply with their requirements.
- Understand Good Documentation Practices
- Assist in the investigation, control and disposition of nonconforming materials.
- Maintain data files, training and competency records.
- Analyze and trend quality metrics to identify opportunities for improvement and participate in continuous improvement projects.
- Identify, facilitate, and perform all necessary measures of the Quality Management System as directed by the Quality Manager
- Create inspection sheets, input data, and inspect core mandrel product when requested
- Audits all DPR's before scanning to make sure they are correct and accurate. If anything needs to be fixed and/or updated, they will discuss with Quality Technicians and crew leads
- Technical reading and often corrections for validations including IQ, OQ, PQ, control plans, PFMEA, OQ/PQ protocols
- Other responsibilities may be assigned as required.
Qualifications
Qualifications
- High school diploma or equivalent
- Document Control Management systems experience preferred or developed specialized skills through job-related training and on-the-job experience
- Able to work with computer hardware and software applications including the internet and MS Office, including Word, Excel, and Outlook
- Professional and effective interpersonal skills
- Foster cooperative team-oriented relationships with all internal customers.
- A familiarity with ISO regulations or demonstrated ability to rapidly develop an understanding of such regulations.
- A high degree of attention to detail , thoroughness and follow-through
- Communication skills (both verbal and written)
Physical Demands
- Viewing a computer screen for extended period of time
- Ability to see to read fine print.
- Must occasionally lift and/or move up to 25 pounds
- Occasional bending and stooping required
- Walking, standing and sitting for prolonged periods of time
Work Environment
- Office and clean room environments