Job Description

Job Title Principal 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.

3 Key Consulting is hiring a Principal Device Quality Engineer - IVD devices SME for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Manager is open 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 provide thought leadership and current best practices surrounding considerations and continued development of internal processes related to control of IVDs. The staff member will report to the Corporate Quality function at the Thousand Oaks, California headquarters.
Train and educate key functional partners and management on regional and international IVD requirements, standards and regulations
Suggest and participate in improvements to the quality system, particularly related to IVDs
Provide Quality leadership for regulatory interactions for IVDs
Review and approve procedures and work Instructions
Specifically, this role will employ 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, Human Factor 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 related experience OR
Master’s degree and 6 years of directly related experience OR
Bachelor’s degree and 8 years of directly related experience OR
Associate’s degree and 10 years of directly related experience OR
High school diploma / GED and 12 years of directly related 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 notified 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 within 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 all levels
High personal integrity 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 Skill Sets

Audits / inspections / quality agreements (purchasing controls)
Quality or Technical experience within 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 within precision medicine

Ability to gain experience from the “pharma” side 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 qualified candidates to send your resume to resumes@3keyconsulting.com 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 share this posting with anyone you think might be interested in applying for this role.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry

Unknown

Company Size

1-10 employees

Headquarters

Simi Valley, CA

Year Founded

2009

Website

3keyconsulting.com

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