Essential Duties, Critical Success Factors, Responsibilities, Authorities and Required Interactions:
Reporting to the Manager of CE Consumables Sustainment, this role will have accountability for creation, maintenance, control, and distribution of all documents necessary to define consumables products for the CE-Biopharma Business Unit and ensure conformance to customer requirements, ISO standards and applicable regulations. The qualified candidate will develop and maintain a comprehensive review, approval & filing system and computer database for all documents to be retained in the document control system. This role will also be accountable to manage document control to ensure that all stakeholders have access to the latest revision of appropriate documentation in a timely manner.
Collect and maintain files of the latest revision level documentation necessary to define product configuration.
Ensure timely distribution of latest revision level documentation to all appropriate users and obsolete documentation removal.
Maintain a computer database of all filed documentation that ensures fast retrieval of documents. Control access and provide user support and training.
Implement changes based on red-lines and format engineering documents per documentation standards
Control and manage appropriate document templates.
Ensure guidelines and definitions are consistently applied across templates and documents.
Advise and respond to queries on document change management by interfacing with document owners and originators of changes, providing prior and current revisions of documents, and running queries and reports.
Review all documentation for accuracy, completeness and consistency in content, format, files and authorizations.
Filing, scanning, copying and electronic notification and distribution of released documentation.
Store and control archived documentation.
Maintain physical security of the document control file cabinets and contents.
Ensure that all document control systems adhere to applicable ISO 9001 and ISO 13485 standards.
Participate in the internal auditing process as required.
Bachelor's degree in field with no less than 5 years of industry experience OR Master's degree in field with 3 years of industry experience OR Doctoral degree in field with 0-2 years of industry experience.
Prior experience with documentation of Life Science or Medical Device products.
Strong business acumen with customer focus.
History of getting results through others, with the ability to work in a matrixed environment.
Strong communication skills, both written and verbal.
Ability to use and apply using logic and critical thinking skills.
Experience with change orders.
Knowledge of document control procedures including database storage, maintenance, and revision control
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page
Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
SCIEX is an equal opportunity employer, and only those candidates who are qualified will be contacted. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.