Danaher Corporation Senior Risk Specialist in Sunnyvale, California
The Senior Risk Specialist will support the risk management process and other quality processes in accordance with FDA and ISO regulations. The ideal candidate will have experience working within the medical device industry with knowledge regarding the complete supporting system structure of a device.
Essential Job Responsibilities:
Strong understanding of Cepheid’s Reagent Tests to support the following:
Independently plans, coordinates, and maintains product risk management files for post market sustainment
Generates, prepares, issues and provides training for procedures in the risk management process
Provides analysis in post market risk data for input into NPD projects
Reviews, implements, or revises risk management quality activities.
Potentially cross trains to support other quality systems processes such as post market support
Collaborates across the organization and builds working relationships with Business Unit and partners to ensure process solutions are compliant, efficient and adaptable to business units, sites and functions throughout the world.
Process driven and comfortable with ambiguity - to apply risk management or other quality requirements to unfamiliar processes
Leads by coaching and engaging teams by learning and understanding their processes – be able to ‘interview’ and ask effective questions
Provides guidance for practical application of the risk management process on development, current business or product improvement projects.
Develops processes and standard work for effective application of risk management for the medical device and component manufacturing.
Assures implementation of best practices for Design Quality and Risk functions to the global organization.
- Complete all assigned and required training satisfactorily and on time
Education and Experience:
BS degree in engineering, technology, or science from an accredited college or university with 5+ years experience OR Master's degree with 2 years experience
Technical expertise with PCR testing
Experience working in a regulated environment
Strong understanding of molecular biology
Knowledge & Skills:
Strong understanding of Medical Device Reporting and differences between discrepant and non-determinate results
Strong understanding of the medical device system structure (Assay, Software, Instrument, Labeling, and Service)
Strong understanding about the premarket development and post market sustainment of a medical device in order to apply risk management process to multiple processes within the business.
Fast learner, and able to quickly become adept at using the Danaher Business System tool set
Able to foster excellent relationships and credibility quickly at all levels of the organization.
Ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives.
Understand what drives policies, practices, and procedures.
This individual needs to understand company’s customers and competition to maximize opportunities and advantages, and search for ways to leverage the company’s current position.
A confident individual who provides a good balance of risk taking and sound judgment in order to deliver optimal results.
Drive goal attainment in others with energy and focus.
Readily accepts responsibility and accountability for project success and key decisions
Thrives in a dynamic and fast-paced environment
Excellent organization and communication skills.
Ability to successfully interact with multiple departments. Demonstrate strong ethics and teamwork.
Ability to handle multiple projects simultaneously, with tight timelines, and progress independently in a timely manner.
Self-motivated to seek out available information
Effective leadership and interpersonal skills
Good written and verbal communication skills
Proficiency in Microsoft Excel, Microsoft Visio and highly agile in all other basic MS Office software.
Experience with Oracle Agile and SalesForce
Ability to present material, instruct, and/or facilitate.
Experience delivering training at various levels throughout an organization highly desired
Exceptional social and interpersonal skills;
friendliness, confidence, giving and receiving feedback, clarity and adapting to different communication styles.
Use active listening skills while observing processes and activities, proactively asking questions to understand
Speak and exercise insight to ensure messages and tone are clear and respectful.
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 here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid