Staff Quality Engineer - CAPA Lead (Critical Care)

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 9, 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. Staff Quality Engineer - CAPA Lead (Critical Care) USA - California - Irvine This Staff Quality Engineer will be part of our growing Critical Care business in Irvine, CA. We are looking for a strong engineer with solid technical knowledge, root cause analysis investigation, and leadership skills. An engineer, which enjoys working in a fast paced and rapidly growing environment. This Staff Quality Engineer will focus on providing ownership and support of all phases of the CAPA process including investigations, robust root cause analysis, development and implementation of corrective actions, and effectiveness monitoring. Additional responsibilities may include performing process improvement projects. Additionally the Staff QE will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Key Responsibilities:

• With the support of subject matter experts (SMEs), lead investigations of complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes based on engineering principles;, perform robust root cause analysis investigations, develop and implement corrective actions, and establish effectiveness monitoring plans
• Manage all phases of the CAPA process for specific events; including documentation, record management, and assembly of robust CAPA files within the CAPA Management System
• Analyze results, make recommendations and develop reports
• Quality Systems Engineering support, including Post-Market Quality Engineering support
• Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution
• Guide others in resolving basic issues in specialized area based on existing solutions and procedures
• Train, coach, and guide lower level employees on CAPA procedures
• Other incidental duties assigned by Leadership A Bachelor's Degree or equivalent in Engineering with a minimum of 6 years relevant experience in the medical device industry required; A Master's Degree or equivalent in Engineering field with a minimum of 5 years of relevant experience in the medical device industry Preferred Qualifications:
  • Relevant CAPA experience for class II electro-mechanical medical devices Additional Talents and General Expectations:
    • Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements)
    • Advanced problem-solving, organizational, analytical and critical thinking skills
    • Strong leadership skills and ability to influence change
    • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
    • Ability to prioritize, plan & evaluate deliverables to established strategic goals--
    • 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
    • ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications preferred. E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 28 Days Ago Full time Req-6169 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 , Staff Quality Engineer - CAPA Lead (Critical Care), Engineering , Irvine, California