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Sr. Quality Engineer, Implant Manufacturing

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 19, 2021

Job Description:

Sr. Quality Engineer, Implant Manufacturing The Sr Quality Engineer will support and lead quality initiatives within the Irvine Implant Manufacturing site, partnering closely with various engineering teams in projects related to Automation, Equipment and Process Validation and introduction of new technology. In this role you will also be working with suppliers on process changes and process validations.
Key Responsibilities:
--- Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Provide technical support for manufacturing optimization, equipment and utilities remediation, procedures, performs investigations and troubleshooting. --- Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. Review validation deliverables for compliance to 21 CFR 11 regulations and GCP. --- Develop, update, and maintain technical content of risk management files
--- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
--- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
--- Train, coach, and guide lower level employees on routine procedures


Education and Experience:
Bachelor's Degree in Engineering or related field, plus minimum of 4 years related industry experience required
(or Master's Degree in Engineering or related field, plus minimum of 3 years related industry experience required).


Additional Skills:
--- Proven expertise in usage of MS Office Suite; CAD experience preferred
--- Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
--- Working knowledge and understanding of statistical techniques
--- Previous experience working with lab/industrial equipment required
--- 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 and adherence to Quality systems
--- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
--- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
--- Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of--influence/control E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.-- 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, Implant Manufacturing, Engineering , Irvine, California

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