Representative of the Corporate Document Control process.
Support the process owner in the Document Control process.
Manage both control of internal and external documents in accordance with regulatory and legal requirements as when as internal requirements.
Support in process optimization.
Responsibilities
Ensure compliance with document control requirements
Monitor and maintain internal standards for document control
Further develop existing QMS documents according to ISO 13485, 21 CFR 820, and
other requirements
Perform Corporate DCC in MyQumas for the Ivoclar Group in accordance with
applicable process guidelines (e.g., participation in system workflows, general system
administration, etc.)
Harmonize business processes across the Ivoclar Group (e.g., corporate processes)
Prepare documentation and conduct software validation activities within the area of
responsibility
Train internal teams on document control standards and procedures within the Ivoclar
Group
Analyze key performance indicators in line with applicable process documentation
and support the preparation of corporate quality reporting (e.g., QTR, GQTR)
Participate in projects (e.g., DMS projects or QMS roll-outs at new Ivoclar Group
locations)
Act as MyQumas Power User and backup for the diverse sites in the Ivoclar Group
Provide OTCS first-level support and perform quality gatekeeping in OTCS as well as
other OTCS related tasks
Perform Training Management for CQM
Professional:
Commercial education with initial training in Quality Assurance/Quality Management,
Software Engineering, Medical Technology, Process Engineering, or a comparable
field.
Initial work experience in Quality Assurance/Quality Management
Ideally, industry knowledge in the field of Medical Technology
Excellent English skills, both written and spoken
Strong MS Office skills (Excel, Word, PowerPoint) and SAP knowledge
What We Provide:
TRAINING: You will work with various members of our team locally and onshore to ensure you are set up for success.
SUPPORT: A close-knit coaching and mentoring system to help you ease into the company and into your role with confidence.
COMP & BEN: Ivoclar believes in compensating employees fairly for their skills and experience and has designed the total rewards package for long-term relationships.
TOOLS: Everything you need to help you do your work will be provided.
WORKING ENVIRONMENT: Ivoclar prides itself on being a family-owned company with strong values so everyone we bring in becomes part of that global family.
