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Principal Quality Engineer - Hybrid Work Environment

Company: ReShape Lifesciences Inc.
Location: San Clemente
Posted on: August 7, 2022

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 ROLE

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 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 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 processes (IQ/OQ/PQ)

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 sterilization/packing requirements

ASQ CQE and ASQ CQA or ISO 13485 Lead Auditor certification a plus

WHAT WE OFFER

Hybrid work environment

Half-Fridays

Business casual dress code

Corporate-sponsored virtual team building events

Medical, dental, vision and life insurance

FSAs, HSAs, long-term and short-term disability

401(k) plan

Employee assistance plan (EAP)

Employee Stock Options

PI185091576

Keywords: ReShape Lifesciences Inc., San Clemente , Principal Quality Engineer - Hybrid Work Environment, Education / Teaching , San Clemente, California

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