About this role
Essential Duties and Responsibilities
- Identify and manage all controlled documentation to ensure compliance with operational, corporate, and regulatory requirements.
- Provide effective and efficient documentation and records management.
- Coordinate scheduling of formal document reviews for site documentation.
- Maintain file system of current drawing revisions and documents of external origins.
- Communicate changes to document control procedures and other relevant information that have been updated or added.
- Dispose of or destroy records and documents securely and properly when retention periods expire.
- Scan and enter material certifications and Safety Data Sheets (SDS) into the system.
- Support customer and regulatory audits by retrieving required documentation.
- Prepare work orders for the production team and verify 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 Certificates of Conformance and ensure customer requirements for shipping are met.
- Read and interpret manufacturing procedures, engineering drawings, customer specifications, and inspection procedures and comply with their requirements.
- Understand and follow Good Documentation Practices.
- Assist in the investigation, control, and disposition of nonconforming materials.
- Interact with customer and supplier material compliance activities.
- Maintain data files, training, and competency records.
- Analyse 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.
- Perform calibrations and schedule outside metrology services.
- Assist with daily yield collection and maintain monthly spreadsheets.
- Other responsibilities may be assigned as required.
Qualifications
Qualifications
- High school diploma or equivalent.
- Experience with Document Control Management systems is preferred, or specialized skills developed through job-related training and on-the-job experience.
- Ability to work with computer hardware and software applications, including the internet and MS Office (Word, Excel, Outlook).
- Professional and effective interpersonal skills.
- Foster cooperative, team-oriented relationships with all internal customers.
- Familiarity with ISO regulations or the ability to quickly 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 periods of time.
- Ability to see and 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.