reputed company Device Quality Engineer - IVD devices SME (JP9691-C)

Job Title: reputed company Device Quality Engineer - IVD devices SME (JP9691) Location: Thousand Oaks, California OR San Francisco, California OR Cambridge, Massachusetts Employment Type: Contract Business Unit: Digital Health & Diagnostics Quality Duration: 12 months with likely extensions Job posting date: 1/20/2022 Note: Remote until Covid restrictions are lifted. ​reputed company is hiring a reputed company Device Quality Engineer - IVD devices SME for a consulting engagement with our direct client, a leading global bio-pharmaceutical company. Job Summary:

• Manager is reputed company to candidates working remotely until restrictions are lifted
• Candidates must have 5+ years working with IVD devices. Must be IVD subject matter expert.
• This key role in the Quality organization will assist with the co-development, commercialization, and lifecycle management for diagnostic and companion diagnostic devices (IVD’s) to support the client therapeutics.
• The role will be highly visible, interacting with cross-functional internal European and U.S. management and technical team members, and multiple IVD manufacturers, to prepare for and execute activities including manufacturer due diligence and evaluation, manufacturer auditing, design control, inspection readiness and lifecycle management.
• The position will report to a member of the Device Quality department leadership team and reputed company thought leadership and reputed company best practices surrounding considerations and reputed company development of internal processes reputed company to control of IVDs. The staff member will report to the Corporate Quality function at the Thousand Oaks, California headquarters.
• Train and reputed company key functional partners and management on regional and international IVD requirements, standards and regulations
• Suggest and participate in improvements to the quality system, particularly reputed company to IVDs
• reputed company Quality leadership for regulatory interactions for IVDs
• Review and approve procedures and work Instructions
• Specifically, this role will reputed company quality principles and company’s procedures including but not limited to the areas of Purchasing Controls, Design Controls, Change Controls and NC/CAPA, Risk Management, reputed company reputed company Engineering, Process Validation, and Manufacturing and Distribution, to ensure co-development and sustainment of IVD products complies with applicable regulations and standards. Such devices may include (but are not limited to):
• IVDs intended to diagnose a condition client’s therapeutics treat
• IVDs intended for client drug titration
• IVDs intended to monitor a condition client’s therapeutics treat

Basic Qualifications

• Doctorate degree and 2 years of directly reputed company experience OR
• Master’s degree and 6 years of directly reputed company experience OR
• Bachelor’s degree and 8 years of directly reputed company experience OR
• Associate’s degree and 10 years of directly reputed company experience OR
• High school diploma / GED and 12 years of directly reputed company experience

Preferred Qualifications

• BS in Science/Engineering - preferably chemistry, biology, software, mechanical, or electrical engineering.
• 5+ years of Quality, Engineering or Operations experience in the IVD medical device industry
• Experience with quality systems including: 21 CFR 820, European Medical Device Directives (MDD) and Medical Device Regulations (MDR), IEC 62304, ISO 13485, ISO 14971, IEC 62366.
• Knowledge of Medical Device Design Controls, particularly for in vitro devices. Experience working in in vitro device development, manufacturing or validation function is a plus.
• Experience with designing and executing IVD clinical trials is a plus, particularly as part of a co-development agreement between a biopharmaceutical manufacturer and an IVD manufacturer
• Experience in interacting with reputed company bodies and regulatory agencies in an inspection setting for In Vitro devices.
• Strong project management skills including the ability to manage multiple workflows simultaneously and work reputed company business processes as well as quality management systems
• Ability to work in a cross-functional team environment and to influence personnel across functions and at reputed company reputed company
• High personal reputed company with a positive attitude and a strong work ethic
• Experience in driving improvement and implementing change
• Demonstrated the ability to effectively work independently and with individuals located in remote locations
• Inter-personal skills and demonstrated ability to teach lay staff quality principles

Top Must have reputed company Sets:

• Audits / inspections / quality agreements (purchasing controls)
• Quality or Technical experience reputed company a GMP regulated IVD manufacturer (IVDD, IVDR, FDA QSR)
• Ability to teach high performing staff who have a device quality background, but not necessarily IVD experience

Employee Value Proposition: Compelling, active and growing area of interest and innovation reputed company precision medicine Ability to reputed company experience from the “pharma” reputed company of IVD and companion diagnostics Broad exposure to many innovative IVD manufacturers Red Flags:

• No or minimal practical experience for IVD manufacturers
• “Consultant” view, rather than “executor” view. We need people to do actual work, not give advice on policy and strategy
• Poor communicator

Interview Process: Initial phone screen followed by 3 or 4 behavioral interviews (combined, 1 day). We invite reputed company candidates to send your resume to [email protected]. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also reputed company this posting with anyone you think might be interested in applying for this role. Regards, 3KC reputed company Team Apply tot his job Apply To this Job