Principal Quality Engineer - Hybrid Work Environment
Company: ReShape Lifesciences Inc.
Location: San Clemente
Posted on: August 7, 2022
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.
ReShape 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 DO
Provide 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
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
Oversee the disposition of non-conforming material and
Develop, prepare, analyze and present trend reports for complaints,
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,
WHAT YOU'LL NEED
B.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 industry
Experience with the validation of medical device manufacturing
Experience with medical device design controls
Expertise in CAPA and SCAR quality subsystems
Knowledge of CAD systems (Solidworks a plus), US and International
regulations, risk analysis methodology, inspection tools and
ASQ CQE and ASQ CQA or ISO 13485 Lead Auditor certification a
WHAT WE OFFER
Hybrid work environment
Business casual dress code
Corporate-sponsored virtual team building events
Medical, dental, vision and life insurance
FSAs, HSAs, long-term and short-term disability
Employee assistance plan (EAP)
Employee Stock Options
Keywords: ReShape Lifesciences Inc., San Clemente , Principal Quality Engineer - Hybrid Work Environment, Education / Teaching , San Clemente, California
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