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Responsibilities:

• Responsible for all activities related to document and change control routing, distribution and release to assure that the latest effective copies are available as required.
• Ensure prompt archiving and storage of all Stryker documentation.
• Timely retrieval of documents and information, as needed to complete investigations and/or reports.
• Subject Matter Expert for document management procedures, update and revise procedures to improve practices and systems by reflecting the current best practices.
• Subject Matter Expert (super user) for the Product Life-cycle Management system.
• Develop and provide coaching, training, clinics, support and service to functions in use of and navigation of the PLM system and execution of documentation & change processes.
• Lead and drive improvement initiatives within the Quality Systems team, participate in multi-functional teams to achieve collaborative results.
• Coordination of different Organization which have to interface in the Change Control Process
• Drive implementation of external Stryker Documents to local QMS, be single point of Contact for Process Owner.
• Effective interface & communication with functional disciplines to ensure efficient and constructive interdepartmental interactions for Documentation aspects.
• Provide training to fellow document controllers, cross functional groups on PLM and regulatory requirements related to Change control.
• Periodic/requested participation in product development team
• Support & comply with GMP/QSR, ISO 13485, CE-mark, and EU MDR requirements.
• Act as designee for document control lead, where appropriate.
• Report on, input to & maintain quality KPIs for trending/management reviews.
• Assist in issue investigations, provides input to correction & resolution, rework, problem solving, and process improvements.
• Maintain an organized, clean, safe & health conscious work environment.
• Assist with company regulatory audit activities, as deemed necessary.

Requirements:

• Candidate must have successfully completed third Level Qualification (Diploma in Business Studies or Administration, or equivalent 2 year certification)
• Candidate must have at least 4 year's relevant experience in a regulated industry, 2 of which within quality systems or equivalent.
• High level of PC skills required, the successful candidate must be highly proficient with Microsoft.
• Have an understanding of archiving systems and methodology and electronic document managing systems.
• Have an understanding of the following standards ISO 13485 and ISO 9000 and CFR Part 820 Quality System Regulations
• The successful candidate must be highly organized and disciplined and be able to demonstrate their ability to meet deadlines with acute attention to detail
• Be a self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
• Be capable of working as part of a multi-disciplined team.