Principal Quality Engineer - Hybrid Work Environment
Company: ReShape Lifesciences Inc.
Location: San Clemente
Posted on: August 4, 2022
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Job Description:
ReShape Lifesciences Inc. is America's premier weight-loss
solutions company, offering an integrated portfolio of proven
products and services that manage and treat obesity and metabolic
disease. Our team is driven by a passion to help patients learn how
to make long-term healthy living a part of their everyday lives.
Our portfolio includes the FDA-approved Lap-Band-- - program, the
investigational ReShape Vest-- --- - --- - System and the recently
launched reshapecare-- --- - --- - virtual health coaching
program.We are located in beautiful San Clemente, California, and
offer a hybrid work environment.THE ROLEReShape Lifesciences has a
great opportunity for a Principal Quality Engineer to join our
team. This role supports R&D Design Control Process, Process
Development, Process Validation, Test Method Validation and
manufacturing with an emphasis on product quality. The Principal
Quality Engineer will need to have strong prioritization and
delegation skills, and will also support material control and flow,
including and inspection.A great fit would be someone who is highly
innovative, with strong engineering analysis and problem-solving
skills, and the ability to work in a cross-functional, dynamic
role.WHAT YOU'LL DOProvide Quality Assurance leadership;
participate on project teams as Quality Representative. Ensures
that principals of Design Control are applied to Product and
Process Changes and New Product Development.Perform detailed Root
Cause Investigation of failed products or processes using various
quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts).
Implements corrective and preventive actions (CAPAs).Oversee the
disposition of non-conforming material and processes.Develop,
prepare, analyze and present trend reports for complaints, as
required.Review and evaluate complaints, customer feedback and
information for quality, accuracy and completeness.Identify,
analyze and manage risk through product life cycle with use of FMEA
and other risk management tools.Review and approve equipment and
process validations: Installation Qualification of equipment,
Operational Qualification (OQ) and Performance Qualification (PQ)
of new processes.Assist with development of new test methods and
test method validation in compliance with FDA and ISO
requirements.Reviews changes to existing products, SOPs, Test
Methods, Process Changes, Design Changes, Labeling/Labels and Field
issues to define the requirements for regulatory submissions and
notifications.Support and/or conduct audits (internal, ISO, FDA and
supplier) and coordinate follow ups on audit findings.Support the
quality documentation system in compliance with FDA and ISO
requirements under the direction of quality leadership; review
quality changes to existing products, SOPs, Design Changes,
etc.WHAT YOU'LL NEEDB.S. in Industrial Engineering, Mechanical
Engineering or Bio-Medical engineering or equivalent experience
with college degree (BS or BA)Strong experience in regulated and
medical device industryExperience with the validation of medical
device manufacturing processes (IQ/OQ/PQ)Experience with medical
device design controlsExpertise in CAPA and SCAR quality
subsystemsKnowledge of CAD systems (Solidworks a plus), US and
International regulations, risk analysis methodology, inspection
tools and sterilization/packing requirementsASQ CQE and ASQ CQA or
ISO 13485 Lead Auditor certification a plusWHAT WE OFFERHybrid work
environmentHalf-FridaysBusiness casual dress
codeCorporate-sponsored virtual team building eventsMedical,
dental, vision and life insuranceFSAs, HSAs, long-term and
short-term disability401(k) planEmployee assistance plan
(EAP)Employee Stock OptionsPI185091563SDL2017
Keywords: ReShape Lifesciences Inc., San Clemente , Principal Quality Engineer - Hybrid Work Environment, Education / Teaching , San Clemente, California
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