Quality Engineer II/III (Production/Manufacturing QA)
Posted on: May 3, 2021
Invitae is dedicated to bringing comprehensive genetic
information into mainstream medicine to improve healthcare for
billions of people. Our team is driven to make a difference for the
patients we serve. We are leading the transformation of the
genetics industry by making genetic testing affordable and
accessible for everyone to guide health decisions across all stages
The Quality Engineer II/III (Production/Manufacturing QA),
reporting to the Manager, Manufacturing Quality Operations - IVD,
will support tech transfer, production scale-up, and Quality
operations activities for In-vitro Diagnostic (IVD) product
development, and implement the Quality Management System (QMS) to
ensure ArcherDX medical devices are manufactured under FDA GMP and
ISO 13485 regulations. The Quality Engineer II/III will also be
tasked with developing quality processes in a high-throughput
Manufacturing environment, investigating quality issues, and
implementing continuous improvement activities to ensure that
production rates are scalable while maintaining Quality
Job performance will involve a variety of activities
- Serves as the process Quality Engineering representative on new
product development and tech transfer projects, and provides
strategic Quality representation across teams.
- Influences across Quality System functions, including, but not
limited to, design, production, assay development, document
control, risk management, etc.
- Develops, implements, and evaluates tools, systems, and methods
for product/process improvement and conformance.
- Applies Lean/Six Sigma principles to identify and implement
improvements in a rapidly-growing GMP manufacturing environment to
increase capacity, reduce lead-time, and improve process flow.
- Collaborates between Development and Production teams to ensure
that Quality and Lean are built into manual and automated
- Provides technical guidance and quality compliance for multiple
areas of the quality system to ensure process and product
- Identifies and supports quality test methods, inspection
criteria, risk assessments, and other processes for new products to
ensure compliance to regulatory standards.
- Perform other duties as assigned by supervisor
- Review, understanding, and compliance with ArcherDX HIPAA
Security policies and procedures.
- Safeguarding the privacy and security of protected health
information and European Union personal data.
- Processing and handling of European Union personal data only as
directed by ArcherDX for purposes of personalized molecular
- Minimum of 5 years of Quality experience in an FDA-regulated
- Minimum Lean/Six Sigma Green Belt certification, preferred
- Recommended ASQ CQE certification, or similar
- Expertise in Quality System requirements, including ISO13485
- Ability to communicate and influence cross-functionally
- Ability to apply Lean/Six Sigma and Quality Engineering
principles in product development and tech transfer processes
- Attention to detail with a strong ability to create and review
- Ability to interact with multiple disciplines, and communicate
clearly and effectively verbally and in writing
- Ability to work independently, and utilize good problem-solving
- Ability to multitask and work within a fast-paced dynamic team
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- Ability to participate with others as a member of the team to
ensure that demanding and difficult projects are handled smoothly
and cooperatively to enhance the success of the projects and
maintain strong relationships within all parts of the company.
- Strong communication and presentation skills
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently
move projects forward.
- Bachelor's degree in an Engineering or Scientific field
In Colorado, our competitive compensation package includes a
base salary starting from $85,000. In determining the final salary
offered, we will evaluate a specific candidate's geographic
location, education, skills, and experience.
Invitae offers a competitive total rewards package, which
includes healthcare coverage, 401k, and a broad range of other
benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and
basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health
and wellness supports
At Invitae, we value diversity and provide equal employment
opportunities (EEO) to all employees and applicants without regard
to race, color, religion, national origin, gender, sexual
orientation, age, marital status, veteran status, or disability
status. We will consider for employment qualified applicants with
criminal histories in a manner consistent with the requirements of
the San Francisco Fair Chance Ordinance.
Keywords: Invitae, Boulder , Quality Engineer II/III (Production/Manufacturing QA), Other , Boulder, Colorado
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