Edwards Lifesciences Sr Quality Engineer – Critical Care in Irvine, California
Edwards' innovative Critical Care organization is seeking a Senior Quality Engineer to support product quality activities for the production and distribution phase. This individual will apply technical principles and methods to ensure compliance with regulatory requirements and Edwards' QMS requirements. The Sr Quality Engineer will also facilitate process qualification and improvement by applying Six Sigma methodology, risk management, verification and validation. We are looking for a strong engineer with solid technical expertise and leadership skills, who enjoys working in a fast-paced and rapidly growing environment.
Identify, validate, and improve products based on investigation of product quality and compliance issues reported from the field as well as issues reported by Edwards’ manufacturing partners.
Ensure completion of PFMEA and manufacturing process validations (IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion.
Initiate and own Non-Conformance Report (NCR) processes, including implementation of Quality Holds and/or Stop Shipments to prevent distribution of non-conforming products. Lead cross-functional team members and perform root cause investigation by applying problem-solving methodologies in identifying, prioritizing, communicating, and resolving product or process non-conformance.
Participate in and own escalation tasks and activities, including Product Risk Assessments (PRAs) and Corrective/Preventive action (CAPA) as determination by investigation.
Support development of moderately complex experiments and tests (including writing and executing protocols) to investigate issues and improve products and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports.
Review, update and maintain technical content of risk management files.
Responsible for quality data metrics analysis, trending, and reporting for monthly and quarterly management meetings.
Provide support/responses during internal and external audits.
Other incidental duties assigned by Leadership.
Education and Minimum Requirements:
- Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering or related engineering field with 4+ years of relevant industry experience in Quality Engineering; OR Master's Degree in an Engineering field with a minimum of 3 years relevant industry experience.
Experience and knowledge of electronic manufacturing, electro-mechanical, and/or cable harness assembly.
Familiar with IPC-A-610, IPC-A-620 workmanship standards.
Knowledge of regulatory requirements (FDA, IEC, CE, etc.), ISO 13485 and ISO 14971 standards.
Additional Talent and Expectations:
Experience in conducting root cause investigation and prepare reports, for negative trends of process or product failures or critical characteristics not being met.
Hands-on experience with device and process investigations.
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
Strong problem-solving, organizational, analytical and critical thinking skills (strict attention to detail)
Demonstrated experience by applying risk management tools (FMEA) to solve complex problems
Basic understanding of statistical techniques.
Ability to interact professionally with all organizational levels and 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 projects.
Provide project direction, coaching, and mentoring for QE I-II as required.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.