Senior Quality Engineer
Location:
Redwood City, CA
Job Code:
14-267
# of openings: 1
Description
Finding a good job is very good.
Finding a good job in a dynamic, growing company is great.
Finding a great job in a world-changing organization is a once-in-a-lifetime opportunity.
Welcome to Proteus Digital Health, which is pioneering a new category of products,
services and data systems based on ingestible computing. Our core technology – the digital
health feedback system – provides an unprecedented view into an individual’s personal
health choices and physiologic response. This care-altering feedback system enables
patients to better manage their health, allows more effective collaboration with caregivers
and clinicians, all while enabling new information-based business models.
Think You Measure Up?
What Amazon did with books, and Apple did with music, Proteus is poised to do with digital
medicine. Come join our unique collection of innovative scientists, engineers, market
makers, designers, doctors, developers, clinicians, and other digital health industry
pioneers, and help us dramatically improve the lives of tens of millions across the globe.
We Are Seeking …
Position: Senior Quality Engineer
Join a great team of hard-working Engineers who are dedicated to doing what they do
collaboratively and have a great time doing it. In this newly created role, you’ll get to provide
QA technical and compliance expertise as part of development teams in establishing and
assuring product quality objectives; assure compliance to applicable regulations; perform
quality activities such as risk management, verification and validation, audit support,
procedure development, product release, documentation review; and define changes to
controlled documents. But it doesn’t end there. Here’s a summary of this exciting
opportunity:
Essential Responsibilities
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Support the evaluation and management of internal and external supplier quality
Responsible for compliance with applicable Corporate and Divisional policies and
procedures
Occasional travel domestically and internationally (2 to 3 times per year)
Plan, execute, report and follow-up on quality system audits (supplier and internal)
Actively participate on cross-functional team projects in a structured business
environment in accordance with internal procedures and external regulations
Monitor compliance with company policies, procedures and applicable regulatory
requirements
Contribute to decisions that are aligned with management objectives regarding work
processes, plans and schedules in order to achieve department objectives
Track and report progress across projects and departmental commitments by
reviewing schedules and due dates, identifying risks, and assisting teams with
contingency plans
Assist in the resolution of project issues by working with team members, project
customers, and others as appropriate
Partner with department and project leaders in developing and reporting appropriate
performance and quality metrics
Stay up-to-date and follow all Quality System procedures related to this role, which
can affect the quality of products or services provided to our customers
Responsible for applying quality engineering principles/methods to manage complex
complaint/quality investigations including driving to root cause and corrective action
Responsible for the application of risk analysis for both new design and
product/process changes. Conduct and lead risk and safety. Utilizes risk tools such
as FMEAs, Hazard Analyses, Control Plans, and Risk Management Plans/Reports.
Provide quality input/support for development of new product design and
product/process changes. Support development of test/evaluation test protocols.
Meet R&D deliverable milestones. Participate in Change Control Board meetings
Responsible for managing all aspects of complex complaint investigations, including
application of statistical methods and analysis and trending of complaint data as a
vehicle for ensuring effectiveness of corrective action(s)
Work effectively both independently and within a multi-functional team (eg. R&D,
Medical, Regulatory, Manufacturing, Marketing and Customers) to resolve
manufacturing issues or field complaints
Work with R&D and Manufacturing teams to ensure that manufacturing and design
documentation is accurate, complete, and fully conforms to
specifications/procedures, including approval of verification and validation
deliverables
Provide quality leadership for cross-functional product/process continuous
improvement initiatives
Support internal/external audits/assessments
Provide training support on key quality management/assessment tools, procedures
and specifications
Are You a Fit?
Qualifications
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Knowledge of Design Control and Risk Management
Knowledge of Verification and Validation activity
Proficient in MS Office suite
Strong written and verbal communication skills
Excellent organizational skills
Great presentation skills
Thrive in a team-oriented, collaborative, cross-functional environment
Successfully manage multiple tasks and function in a fast-paced environment
Experience
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6 to 8 years of experience in an FDA regulated industry (Biotech, Pharma or
Medical Device manufacturing)
Proficient in project planning, statistical analysis of Quality data, software validation,
FDA QSR, International Standards i.e. ISO 13485:2003, ISO 14971:2000; Medical
Devices Directive (MDD)
Education
Bachelor's Degree in Engineering, Software, or related science/technical field or an
equivalent combination of education and work experience
Reasoning Ability
Ability to apply principles of logical thinking to a wide range of intellectual and practical
problems
Physical/Mental Demands
The physical and mental 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; use hands to finger,
handle, or feel; reach with hands and arms; talk and hear. The employee is occasionally required to stand
and walk. The employee may occasionally lift and/or move up to 10 pounds. Specific vision abilities
required by this job include close vision, distance vision, depth perception, and ability to adjust focus.
Ready for the ride of your life? We’re looking forward to receiving your resume!
We provide our employees with a great benefits package, which includes: medical/dental/vision insurance,
401K, paid time off (PTO)—including your birthday off, employee stock options, a bright & awesomely
designed physical work space, a complimentary wearable device (i.e. Fitbit), fitness centers, and free food.
About Us: Proteus has received FDA market clearance in the U.S. and a CE mark in Europe for its wearable and ingestible
sensor devices. Headquartered in Redwood City, Calif., Proteus is privately held and funded by Carlyle, Essex Woodlands,
Kaiser Permanente, Medtronic, Novartis, Otsuka, Oracle, ON Semiconductor and other investors. For more information please
visit www.proteus.com.