Senior Quality Engineer
Location: Irvine, CA
As a leader in thermal technology, we design, develop, and manufacture heating, cooling, and ventilating devices for diverse global markets. With our employees, we pioneer and shape markets for comfort devices while seeking new ways to drive value for our customers. We employ approximately 10,000 people at twelve locations in North America, Europe and Asia.
In the field of Product Quality in Irvine, CA we are looking for you to strengthen our team as soon as possible as a Sr. Quality Engineer.
SUMMARY: Responsible for maintaining and improving Gentherm’s overall product quality in the upfront product development phases. Responsible for quality system support for product development projects; provide inputs to product designs from a quality perspective; work closely with product development to develop test strategies for product designs and analyze the risk associated with these designs. This position will work with a global organization of project teams, quality engineers located at headquarters and plants, Gentherm satellite offices and with customer quality teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Implement ISO9001:2008 and ISO9001:2015, and ISO26262.
- Creates, implements and reviews quality management system related procedures, instructions, forms, records and documents related to corporate quality related activities.
- Drive the project team during the execution of the APQP processes to ensure quality is integrated into all product development work products.
- Oversees project compliance in APQP, PPAP, FMEA, and supplier related evaluations.
- Lead interface with Tier 1 and Tier 2 customer quality teams to proactively mitigate risks and issues within the product development phase. Maintains customer quality contacts.
- Drive the project team through the requirements management process ensuring that requirements are properly captured, analyzed, traced, communicated and controlled throughout the product development phase.
- Supports the project team in linking the post SOP FMEA failure catalogs into the new program FMEA catalogs in the product development phase.
- Assists in the development of DFMEA, PFMEA and Control plans.
- Lead driver of the customer Part Approval with interface to the project team and manufacturing plant to deliver a flawless customer Part Approval package.
- Drive the project team in planning the verification and validation activities that correspond to the risk level determined by the product design.
- Supports the project team in developing prototype control plans, attending prototype builds and ensuring the build performance metrics are captured and integrated into the next build.
- Actively engaged with corporate quality related initiatives: TS16949, APQP, QMS, PPAP, FMEA, Automotive SPICE, ISO 26262, and ISO Audits.
- Develop, create and update, as appropriate, procedures for incoming, in-process, and final inspections for new/existing product development that correspond to the risk level determined by the product design.
- Work closely with corporate warranty group to monitor warranty performance and customer returns for previous or equivalent programs to infuse lessons learned into the new program designs.
- Analyze corrective actions for completeness for related launch concerns, and work with supplier or plant quality to closure.
- Leads team in gathering lessons learned, warranty data, software defects and design transfer issues from the previous project and during design development. Ensures this data is analyzed, reviewed and systemic corrective actions are taken within the project.
- Support the project team in the Design transfer review ensuring areas of design, process, risk analysis, process control, supplier control, repair, service, open issues and continuous improvement items are detailed appropriately to ensure a flawless transfer of the project from design to manufacturing.
- Perform reliability analysis of the product design and develop mitigation strategies to ensure reliability targets will be realized during the launch of the product.
- KPI tracking and maintenance.
- Attend product part reviews and enter data into customer system(s).
- Perform product design risk analysis and develop mitigation strategies.
- Educate product development on the use of risk management tools, statistical methods, design process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
- Continuously work to improve quality related activities and relationships between plants, program management, engineering and suppliers encompassing the entire product development process activities and process strategy development.
- Ability to prepare the organization for external audits and interface effectively with auditors.
- Participates in internal and external audits, including FDA and ISO audits, and be involved with Corrective Action Preventative Action (CAPA) projects.
- Support customer and registrar quality audits, meetings and supplier days.
EDUCATION and/or EXPERIENCE: BS in Quality, Engineering, Electronics or other technical field. Minimum of 5 years quality related experience related to automotive, medical or aerospace products and/or electronics.
- Familiarity with common related product quality requirements. Receiving inspection, process auditing, dock audits…
- Working knowledge of ISO9001:2008 and ISO9001:2015
- Must be a team player and have the ability to work effectively with other global regions.
- Must be able to interface with customer quality personnel effectively.
- Excellent organizational skills as related to common quality requirements.
Must be computer literate, with the ability to use MS Word and Excel to create reports, spreadsheets, and presentations. Must have excellent communication skills and be able to effectively work with others in a team environment. Must be able to read and interpret engineer drawings and specifications.
Gentherm is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, genetic information, sexual orientation, gender identity, disability or protected veteran status.