Supervisor, Documentation

hace 2 semanas

Tijuana, México Merit Medical Systems Inc. A tiempo completo

Work Shift:
DAY
Work Schedule:

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

ESSENTIAL FUNCTIONS PERFORMED

1. MANAGEMENT RESPONSIBILITIES

Supervises document control function by:

- Selection, Coordination of assigned work, Performance Appraisals and Implementation of Disciplinary Procedure (where appropriate) with coordination and consultation of the Department Head.
- Identifying and making provision for required training to ensure proper and efficient completion of all document control assignments.
- Development and direction of annual ‘Document Control Goals’ to ensure continuous growth of personnel, document control system improvements.
- Acts as a resource for various departments in resolving their Document Control needs and makes recommendations for policy or procedure reformation when applicable.
- Establish relationships and builds confidence among department staff, Engineering, Marketing, R&D and other various customers.

2. DOCUMENT CONTROL
- Provide training and guidance to Document Controllers on key functions relating to Document and Data Control ensuring compliance to internal / external standards and competency in the following is achieved:

- ECN Process:

- Assign Document Number (GPS, MPS, QAP, Forms, and Tables etc.).
- Assign ECN Number(s) - new or revised documents.
- Ensure appropriate approval is obtained.
- Process ECN (Electronically & Hard Copy Issues, History Master Copy, Obsolete Document Removal).
- Assign PPS Part Numbers; Sub Assembly Item Number; Finished Good Item Numbers (in conjunction with Marketing); Routers:

- Activate New Items (all Orgs.).
- Deactivate (Obsolete) Items (all Orgs.).
- Update Item Revisions.
- Device Master Record Generation:

- Generate BOM (Engineering).
- Generate Router (Engineering).
- Initiate ECO (Oracle ECNs) to initial release to manufacturing.
- ECO Documentation & Approval:

- Respond to Oracle Alert for ECO (Internal / Customer Service).
- Ensure appropriate approval is obtained.
- Work Order Redline (where appropriate).
- Implement ECO (Electronically & Hard Copy Issues, History Master Copy, Obsolete Document Removal).
- Maintenance, control and update of ‘Label View Software’.
- Assign Laboratory / Production Control Books.
- Assuring that appropriate security is provided for each document and record.
- Providing visibility of retained documents and locations to users; assures that documents are readily available to authorized personnel.
- Maintaining adequate filing system for all quality records as listed above and DHR (Device History Records - Work Order Files) to ensure easy retrieval (ECN, ECO, Master Copy,
- History Copy, DMR) ensuring internal and external retention requirements are complied with.
- Performance of above listed duties as required.
- Co-ordination of documentation flow between site and other Merit Facilities.
- Provide training and guidance to production, support groups and customer service in ECN / ECO initiation.
- Document Control System improvement identification and implementation.
- Document Control Representative on all project teams (where required).

3. GENERAL
- Generation of Document Control Monthly Report.
- Generation, update and control of ‘cheat sheets’ for routine system tasks.
- Quality Assurance input in all Training programs.
- Quality System improvement identification and implementation (as delegated); on related Quality System Improvement Projects.
- Initiation of initial release / document changes ECN/ECO for procedures relevant to all tasks.
- Perform other related quality tasks as required by superiors.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
- Lifting - Not to exceed 50 lbs. - local practice may apply
- Writing
- Sitting
- Standing
- Bending
- Visual acuity
- Color perception
- Depth perception
- Reading
- Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS
- Education and/or work related experience equivalent to a Bachelor's Degree in a business or engineering related field.
- Work related experience of at least five years, with two of those years in supervision.
- Knowledge of quality principles as defined in the regulations and the ability to utilize these methods in a manufacturing environment.
- Working knowledge of and experience with Global Regulations (e.g. U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, Canadian Medical Device Regulation (CMDR), JPAL/JGMP etc.) as applicable to the department.

COMPETENCIES
- Self-directed/starter: Ability to work under strict time constraints; meet deadlines in a timely manner with mínimal guidance.
- Leadership: Ability to lead, motivate and develop staff; set the pace / standard for your group; ensure that work c

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