Quality - Document Control Specialist

Viant • Vega Baja, PR

4d

About The Position

The Quality - Document Control Specialist will be responsible for reporting training and KPI metrics, leading compliance and CRB meetings, managing changes to Bill of Materials (BOM), reviewing and updating documents, supporting various projects related to injection molding and combination products, and maintaining the integrity of the quality systems procedures. Additionally, the employee will assist in audits, ensure customer requests are addressed, verify manual mixing processes, inspect incoming raw materials, and manage the record retention area. The employee has the authority to make decisions regarding the review and update of quality systems procedures, BOM changes, document change orders (DCOs), and incoming inspection processes. They also have the authority to lead compliance meetings and ensure adherence to audit requirements.

Requirements

• Strong organizational, written, and project management skills.
• Attention to detail, particularly with documentation and compliance.
• Effective communication, both verbal and written, for internal and external interactions.
• Analytical thinking for reviewing DCOs, ECOs, and phase reviews.
• Knowledge of quality management systems and regulatory standards.
• Proficiency in handling customer requests and audit preparations.
• Strong interpersonal skills.

Responsibilities

• Report training metrics as required.
• Report KPI metrics as required.
• Lead Compliance and CRB meetings.
• Make necessary changes to BOM.
• Review DCOs and ECOs.
• Support Injection Molding and Combination Product projects by reviewing DCOs, ECOs, phase reviews, and requests made by Project Managers, Project Engineers, and Customers.
• Review and update quality systems procedures and related forms as required.
• Assist with regulatory, external, internal, and customer audits.
• Assist with the completion of Certificates of Compliance (COCs).
• Handle customer requests related to procedures and COCs.
• Verify the manual mixing (resin and colorant) process and review related documentation.
• Assist with incoming inspection of raw materials.
• Responsible for record retention area.
• Identify and destroy documents after the required retention period is complete.
• Provide new and/or revised manufacturing documents to manufacturing areas and ensure that obsolete documents are removed upon updates.
• Make IT tickets for Master Control accounts, BMRAM accounts, password resets, among others as required.
• Assist with New Employee Orientation onboarding activities such as creating and presenting overview presentations.
• Perform other functions as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed