Website TalentBurst, Inc.
TalentBurst, Inc.
Company : TalentBurst, Inc.
Position: Pilot Operations Senior Quality Engineer, Req#: (phone number removed)
Location: Irvine, CA (100% Onsite)
Duration: 8+ Months Contract
Job Description:
This Pilot Operations Sr Quality Engineer role starts with the opportunity to partner on the development of delivery systems for the Transcatheter Heart Valve (THV) Business Unit as a part of the client’s Global Supply Chain. This cross functional partner will (1) interact with various functional departments to accomplish compliance and implementation of quality goals with a primary focus on quality operations for Pilot manufacturing, (2) work with THV new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies and (3) support product transfer from Pilot manufacturing to receiving site manufacturing facilities.
Imagine how your ideas and expertise can change a patient’s life. Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of the client’s innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem-solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will enable you to optimize product development to impact patients around the world with pioneering technology.
Aortic stenosis impacts millions of people globally, yet it often remains underdiagnosed and under-treated. The client’s groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
Education and Experience:
Prior experience in medical device manufacturing or operations preferred
Experience with computerized Manufacturing Execution System (MES) preferred
Bachelor’s Degree in a relevant Engineering field plus a minimum of four (4) years of medical device industry experience required
Master’s Degree in a relevant Engineering field plus a minimum of three (3) years of medical device industry experience required
Additional Skills:
Strict attention to detail
Substantial understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering
Strong problem-solving, analytical, and critical thinking skills
Exhibits professional communication (e.g., written and verbal) and interpersonal relationship skills, including consultative and relationship management
Ability to manage competing priorities in a fast-paced environment
Thrives in a collaborative team environment, including inter-departmental teams and key contacts representing the organization on contracts or projects
Advanced knowledge of statistical techniques and analytics (experience in Minitab preferred)
Demonstrates strong leadership skills and ability to influence change
Knowledge of applicable FDA regulations for the medical device industry
Ability to interact professionally with all organizational levels, including Sr Management, cross-functional teams and external partners
Job Responsibilities:
Work with new product development teams to help them efficiently navigate the client’s Quality System in order to build quality system test samples and human-use products according to project schedules
Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes
Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
Develop/drive improvements for inspection test methods
Lead test method validation activities for in-process inspections
Facilitate and oversee the Material Review Board to disposition potentially non-conforming human use products
Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements
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