Our client, a medical device company in Galway are currently looking to recruit a Documentation Specialist for their site.
- Provide support to own department and site as required, including Audit support, troubleshooting CN/licence issues. Own and manage department mailboxes such as Documentation Services mailbox and BPL mailbox.
- Involved in metrics planning and reporting.
- Networking: Represents the documentation department and PLM as needed; Builds relationship with other functional areas and departments; Service as liaison for national and international documentation/PLM BPLs.
- Masters, explains and applies data management tools (PLM and SAP).
- Detailed understanding of procedures used within the Documentation Services Group and basic understanding of ISO13485 and CFR/GMP requirements.
- Detailed understanding of procedures relating to PLM (corporate and other) and responsible for ensuring that their requirements are met.
- Critically examines existing procedures used within the Documentation Services Group and update as required to ensure conformance to Regulatory requirements.
- Demonstrates basic knowledge of medical device manufacturing process controls and quality system, including audit and CAPA (Corrective and Preventive Action).
- Facilitate and roll-out training to new and existing PLM users both in Galway and in other sites, as required. Support the management of licences (e.g. updating mail listing).
- Process Improvement: Using own initiative, initiate and complete continuous improvement projects as requested.
- Serve as a liaison between the GSP (Global Systems & Process) Team and users at a site (e.g. troubleshooting, project/document type creation, etc.); Prioritize and submit continuous improvement requests to the GSP team; Communicate GSP and PLM information to the users; Coordinate local PLM initiatives; Utilize/leverage a group of Subject Matter Experts (SMEs) to achieve local PLM goals; Oversee future global PLM initiatives at the site (including system testing); Support the linking of users to Groups/Roles; Manage Data Migration cleanup/validation procedures (for newly acquired data).
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- Holder of HETAC Level 7 in a relevant discipline
- Good understanding of quality systems and change management.
- Proficient in Microsoft Word & Excel.
- Good understanding of Product Data Management systems. Detailed knowledge of PLM and SAP would be an advantage.
- Previous experience (3-4 years) in a Quality Field (Documentation), coupled with a knowledge of the regulatory requirements for the Medical Device industry would be desirable.
- Strong team member with the ability to identify and drive quality improvements.
- Demonstrate excellent communication and interpersonal skills.
- Position requires attention to detail and excellent organizational skills.
- Ability to work on own initiative without supervision
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