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Sr Quality Engineer - Pilot (THV Programs)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 10, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Sr Quality Engineer - Pilot (THV Programs) USA - California - Irvine This position will perform Quality Operations function for THV delivery systems as part of Global Supply Chain Pilot Manufacturing in Irvine. The incumbent will interact with various functional departments to accomplish compliance and implementation of Quality goals with a primary focus to lead quality operations for pilot manufacturing. This position will work with new product development teams in the manufacturing of products for feasibility studies, clinical builds and first in human. This role will also support the product transfer from the Pilot Operations into the commercial manufacturing facilities. Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

Key Responsibilities:
--- Work with new product development teams to help them efficiently navigate the Edwards' Quality System in order to build quality system test samples and human use product 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) --- Support product transfer from Pilot to the manufacturing sites.
--- Drive Implementation of Critical Control Points on Pilot product manufacturing lines consistent with Edwards CCP methodology.
--- Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
--- Develop / drive improvements for inspection test methods
--- Lead and establish project plans to ensure Pilot QE deliverables are completed per project schedule
--- Facilitate and oversee material review board to disposition potentially non-conforming human use products
--- Support IQ/OQ/PQ for manufacturing equipment's in the Pilot lines.
--- Track product yields and defect rate and use data to report metrics at Quality Data Reviews and drive process improvements

Education and Minimum Requirements:
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering or related engineering field with 4+ years of medical device industry or relevant experience in another highly regulated industry; OR Master's degree or equivalent and internship, senior projects, or thesis in Engineering field and 3 years of relevant medical device or highly regulated industry experience Preferred Qualifications: Engineering experience in the manufacturing of class III delivery systems Additional Talents and General Expectations:
--- Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
--- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
--- Basic understanding of statistical techniques
--- Previous experience working with lab/industrial equipment
--- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
--- Strong problem-solving, organizational, analytical and critical thinking skills
--- Substantial understanding of processes and equipment used in assigned work
--- Good leadership skills and ability to influence change
--- Knowledge of applicable FDA regulations for medical device industry
--- Strict attention to detail
--- Ability to interact professionally with all organizational levels
--- Ability to manage competing priorities in a fast paced environment --- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 3 Days Ago Full time Req-7513 About Us Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.-- For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Keywords: Edwards Lifesciences Gruppe, Irvine , Sr Quality Engineer - Pilot (THV Programs), Engineering , Irvine, California

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