Overview
Quality – Document Control Specialist Jobs in Vega Baja, Puerto Rico at Viant Medical
Title: Quality – Document Control Specialist
Company: Viant Medical
Location: Vega Baja, Puerto Rico
Title: Quality – Document Control Specialist
Position Description/Responsibilities:
The employee 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.
Position Authority:
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 com compliance meetings and ensure adherence to audit requirements.
Essential Functions:
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 of 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.
Skills:
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.
Physical Requirements:
Ability to sit or stand for extended periods while reviewing documentation. Capacity to lift and move boxes or records in the retention area. Regular manual handling of materials during the inspection and mixing processes.
Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.
Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
