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PD Documentation Control Associate in Orange, California at KaVo Kerr

Date Posted: 5/10/2019

Job Snapshot

Job Description

Job ID: KAV003969

About Us

KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community.  KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential.  KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.


Description

Position Overview:
The Product Development Documentation Control Associate is a hands-on professional, experienced in the creation of project files and folders, that are easy to be updated and maintained. He (she) is responsible for monitoring and controlling all documents created during a product development cycle, from concept and definition of requirements to system design architecture, definition of component specifications, component development, verification and validation testing, to product commercialization and sustaining.

Essential Duties and Responsibilities:
• Creation of project folders to ensure design control compliance and access to product DHF and TF with easy interface to the location and integration of documentation. 
• Interface with key partners as part of the documentation control cross-functional team ensuring access to detailed product requirements, engineering specifications, system architecture, detailed component specifications, verification and validation test protocols and reports, and regulatory submissions of medical devices.
• Ensure all project documents are filed, controlled, and updated according to regulatory and document control requirements.
• Manage the Device Master Record and the interfaces and dependencies across files and folders
• Participate in defining project folders, ensuring design control files are correctly created and maintained; ensure easy reference to documents common to eDHF, eTF, Risk Management File, Design Output, DMR and confirm folders meet applicable quality and regulatory standards 
• Follow a disciplined product development process and participate in product documentation reviews, ensuring design and documentation traceability, and the traceability between design outputs and design inputs.

The Candidate Should Possess:
• Capability to organize project documents in document folders and files that use the eDHF and TF standards
• Input and accuracy of product development documents within a project database
• Knowledge of project folders’ creation and maintenance
• Familiarity with design document formats – Body, Title Block, Revision Block
• Prepare design control documents for filing and maintenance - Scanning, copying, etc…
• Desired - Familiarity with standards such as: Quality System Regulation – 21CFR820, Quality Management – ISO 13485, Risk Management – ISO 14971, EU Medical Device requirements – Council Directive, 93/42/EEC, Medical Electrical Equipment – EN 60601

Job Requirements



Qualifications

Qualifications:
• Undergraduate student seeking summer internship
• High School Graduate

Abilities: 
• Strong interpersonal skills, organizational skills, and time-management skills
• Ability to communicate effectively across the enterprise, as well as various groups such as Regulatory, QA/QC, Supply Chain, internal customers (Marketing, Customer Service, Sales) and external suppliers
• Very flexible and motivated
• High level of commitment to the success of a project
• Problem solving
• Detail oriented, dependable, with a “can do” attitude

Physical Demands: 
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified 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. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.


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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.