Danaher Corporation Document Control Specialist in Kloten, Switzerland
Danaher Company Description
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single tooth to fully edentulous indications. We offer dental implant systems, high-precision individualized prosthetics and CAD/CAM systems, diagnostics, treatment planning, guided surgery solutions and biomaterials. We support customers throughout their professional and practice development. Our headquarter is in Zurich, Switzerland, and we have around 34 direct sales organizations worldwide. Nobel Biocare is a member of the Danaher Corporation, a diversified technology leader.
Our Global Quality & Regulatory organization continues its journey to come together into one cross-functional, collaborative operating unit in order to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of our customers and patients across the globe.
This strategic role as a Document Control Specialist will interface with multi-cultural/multi country locations with the primary responsibility to implement and maintain an effective Nobel Biocare Document Control System and Configuration Management System within SAP, for all baseline and controlled documents which are compliant, effective and capable of meeting regulatory, quality and company requirements for good documentation practices, in projects within Nobel Biocare Systems. The Document Control Specialist develops the document control and configuration management policies and procedures, and is responsible for providing good documentation practices training for all associates globally.
As process owner of the Global Document Control, and Records Management Process, this position is also responsible for compliant and efficient handling of change requests and change orders globally for Nobel Biocare.
The Document Control Specialist collaborates with the Head of Quality Management System in the maintenance of the Change Management Process. The Document Control Specialist also creates and develops structures and quality relevant training related to document control for all associates together with other stakeholders.
Strong relationships must be established with key stakeholders such as Global Process Owners, Change Management Process and IT. The key task of this role is the continuous improvement of the Document Management. The job holder is accountable for: * Tracking the status of change orders (ECO) and associated documents within the change control system * Ensures appropriate ECO approvals are obtained and assures that changes made to ECOs are controlled, all requirements captured in the relevant affected documents * Train globally all other sites on the Document Management system * Follow up on Daily Management for Document and Change Control * Chair the Change Approval Board (CAB) meetings for documentation changes in Zurich * Act as deputy of the Change Control Process owner * Support projects for SAP DMS improvements * Review and approval of quality related documents, including change requests (e.g. SOP, Work Instructions, TPL)
* Strong Quality Management experience supporting large, multi-site, global organizations in medical device industry with significant exposure to requirements of ISO 13485, CFR 820, GMP, GDP, MDSAP, MDD/EU MDR * Medical Device regulations regarding Document Management. * SAP Document Management System knowledge is a plus. * Development and Management of trainings in a Medical Device environment is a plus. * Strategic and analytical thinking combined with operational capabilities. * Project Management and team building capability. * Capability of working cross-functionally. * Sound SAP knowledge is a plus * High quality & compliance awareness and mindset * Sense of urgency but also steadiness in handling the daily business. Must be very reliable and trustworthy. * Strong communication, presentation skills and excellent in developing training materials * Experience in Quality system and process system development. * Training experience. * Experience in process performance measurement, IT/Business integration and document management. * Experience in working in the medical device industry, is a plus. * Self-driven personality with high analytical and conceptual thinking as well as excellent interpersonal skills * Highly goal-oriented and problem solving, negotiation, and communication skills, with the ability to perform in a complex and global environment * Very good English skills. Other languages are an asset * Cross-functional work capability; * Ability to work with all management levels incl. Executive Management level; * Strong communication & influencing skills. * Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management to ensure process solutions are compliant, efficient and adaptable to business units, sites and key business processes and functions throughout the world. * Establish control measures and maintain oversight on key document management system activities such as system configuration, projects, process developments and improvement, including Business Process Management * Assure that there are no significant interruptions to the business due to quality or compliance issues * Provide continuous process improvement and consultation and support of the Quality Management System as required, at the local Nobel Biocare Systems subsidiaries and sites. * Maintains oversight, tracking, and escalation for Document Management Systems, takes action to ensure process are maintained per company policies and industry standards. * Implements/modifies document management system to address changing regulations or industry standard, providing regulatory interpretation and guidance where required for instance the new Medical Device Regulation and local regulations affecting the document management system * Pragmatic but compliant application of the regulatory requirements and internal procedures. Customer oriented communication style and prioritization of issue handling. Capable of communicating with associates from other departments.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
/*To be considered for this role, applicants must be either Swiss citizens, EU-nationals or have the legal right to live and work in Switzerland. */
For agencies:please, note that we only accept direct applications. Submission of candidates from unsolicited third parties does not create any implied obligation on the part of Nobel Biocare/ Danaher group
Organization: Nobel Biocare
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Switzerland-Zurich-Kloten
Req ID: NOB002806