Quality Assurance Manager - (JP10466)
Company: 3 Key Consulting
Location: Cambridge
Posted on: April 1, 2026
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Job Description:
Job Title: Quality Assurance Manager - (JP10466) Location:
Cambridge, MA. 02138 Employment Type: Contract Business Unit:
Combination Product Operations Quality Core Duration: 4 months
(with likely extensions) Posting Date: 06/20/22 Notes: Only
qualified candidates, please. 3 Key Consulting is hiring a Quality
Assurance Manager for a consulting engagement with our direct
client, a leading global biopharmaceutical company. Job
Description: This role provides quality oversight with regards to
the development and lifecycle management of test and inspection
methods and fulfillment of regulatory commitments. Potential scope
of products with regards to test and inspection methods includes a
wide range of devices, raw material components, and constituent
parts, such as: Needle protection systems, fluid transfer devices,
pen injectors, automatic pen injectors, and micro-infuser delivery
pump systems. The qualified candidate will both lead and/or support
technical teams to ensure successful method development or
remediation and/or fulfillment of regulatory commitments, provide
quality oversight to one or more cross-functional teams to utilize
technologies and methodologies that support short-cycle robust
development, accelerated compliance efforts, and/or
remediation/improvement opportunities. The Quality Assurance
Manager will also provide Quality oversight of quality records such
as Deviations, CAPAs, Change controls and review/approval of
physical test methods documents. Basic Qualifications: BS or BE in
Engineering and previous experience in the medical device and/or
pharmaceutical industries 8 years current experience with
engineering processes/procedures and quality tools. - Major
contributions to or the leadership of projects from development
through the 510k and PMA approval process. Experience with material
& test specs generation, protocol & report writing, process & test
development, prototyping, design verification/validation, DOE/SPC
process optimization & validation (IQ, OQ, PQ), P/DFMEA. Product
design/development (design control) from concept to post product
launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
Experience in test or inspection method design and development -
Small scale device assembly and/or benchtop testing experience.
Experience with Automated Test Equipment (ATE). – Experience with
regard to Measurement Systems Analysis/GRR principles, including
study design/execution/troubleshooting Experience with Deviations,
CAPAs, Change controls and document review/approval Strong critical
thinking, problem solving, risk assessment, and risk management
skills. Must be capable of working on multiple projects in a
deadline driven environment. Top Must-Have Skill Sets: Project
management skills Experienced with processes involved in test,
inspection for a wide range of devices, raw material components,
constituent parts (needle protection systems, fluid transfer
devices, pen injectors, automatic pen injectors, and micro-infuser
delivery pump systems. Experience with quality records Experience
with physical method validation, qualification and transfers Day to
Day Responsibilities: Work with a cross functional team to ensure
compliance to design controls and fulfillment of user needs Work
with cross-functional teams to develop, qualify, and transfer
physical test or inspection methods Review and approve physical
test method design documents, validation, qualification and
transfer documents Review and approve quality records (deviations,
CAPA/EVs, change controls) Lead problem solving and lean
improvement projects. Work cross-functionally and globally with
individuals and project teams within Final Product Technologies
Quality and the Final Product Technologies Engineering groups and
their stakeholders in Marketing, Operations, and Development.
Ensure compliance to design controls and fulfillment of user needs
during test or inspection method development or design changes,
including proper and compliant integration of different subsystems
as required. Provide quality oversight and guidance regarding the
development of process control plans and implementation of process
improvements/changes. Work with cross-functional teams to develop,
qualify, and transfer physical test or inspection methods. Provide
comprehensive quality guidance and advice to counterparts and
stakeholders. Provide Quality oversight of quality records such as
Deviations, CAPAs, Change controls and review/approval of physical
test methods documents. Red Flags: Lack of any quality experience
and/or device experience. Interview process: Phone interview
followed by panel interview We invite qualified candidates to send
your resume to resumes@3keyconsulting.com . If you decide that
you’re not interested in pursuing this particular position, please
feel free to take a look at the other positions on our website
www.3keyconsulting.com/careers. You are also welcome to share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Boston , Quality Assurance Manager - (JP10466), Science, Research & Development , Cambridge, Massachusetts
