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Position scope / summary
Document Control supervisor is responsible for performing administration for the document control process and releasing of documentation for finished goods.
Participate on customer audits and audit activities including audit responses.
Co-responsibility to ensure that all associated documentation and procedures associated with areas of responsibility are in compliance including trending and reporting of these activities.
Essential duties and responsibilities
Supervising change control activities
Administration and control of quality system documentation to ensure that the adequate documentation and copies are distributed and are available in the point of useand to prevent the use of obsolete documentation
Administration and Control quality records according to retention period established (e.g storage and retrieval)
Administration and control of customer and external documentation.
Supervision and control of product releasing documentation and CoCs documentation
Maintain a clean and organized work area
Promote and maintain a culture and attitude of continuous improvement, working within the company team to make it more efficient, safety and an enjoyable place to work
Collaborate with process owners and department personnel to change, improve, and create process documentation such as forms and standard operating procedures basedon Good Manufacturing and documentation Practices
Participation during audits as required
Environmental working conditions
Able to travel.
Able to work in a restricted environment as prescribed by the QSR’s.
Must have an excellent work ethic and maintain safety awareness.
Microsoft Office experience (word, outlook, excel)
Minimum 3 to 5 years’ experience in Document Control area in the medical device industry
Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485
Strong communication skills (verbal, written and presentation)
Must have good interpersonal and negotiation skills.
Must have experience and working knowledge in the Quality discipline, Medical Device manufacturing.