The Quality Engineer, Electrolyzers will drive continuous quality improvement through development and use of a customized QMS, KPIs, effective root cause analysis and problem resolution. The Quality Engineer will also be responsible for product environmental, safety and regulatory compliance. The role also requires close interaction with the supply chain, manufacturing and other cross-functional departments to ensure that designs meet all cross-functional requirements. The ideal candidate must be self-motivated, able to handle multiple project assignments and willing to learn and adapt in a fast-paced engineering organization.
Core Duties and Responsibilities:
- With support from internal and external expertise, develop, implement and maintain a certified QMS to ISO 9001:2015, with compliance to HSM10 as a Manufacturer of Part Qualified Components.
- Work with Manufacturing and Engineering teams to develop and revise effective procedures that comply with ISO 9001:2015 QMS requirements while maintaining lean operations.
- Provide training and support to operations personnel in all aspects of quality.
- Conduct QMS audits to drive process standardization, waste elimination, and compliance to ISO 9001:2015 standard.
- Provide support for product development and new product introduction process (NPI), including technical benchmarking and capability assessments
- Collaborate with design engineers to develop robust inspection and verification test strategies to ensure safe, reliable products are implemented.
- Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards.
- Develop IQ/OQ/PQ for new equipment and fixtures and execute verification / validation qualifications.
- Review design specifications and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and confirm quality requirements prior to successful design transfer to manufacturing and suppliers.
- Lead and/or participate in complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis; apply root cause analyses using 5Why, Fishbone diagrams etc; drive implementation of solutions to prevent recurrence of root causes.
- Participate in Engineering Change Order process (ECO) and New Product Introduction process (NPI). Develop quality control plans and risk assessments reviews.
- Maintain Calibration program. Ensure tooling and equipment is scheduled for calibration at defined intervals. Maintain calibration records.
- Monitor, communicate and improve key Quality KPI’s, DPPM and waste.
- Aid manufacturing in the evaluation and qualification of new suppliers and materials. Lead and participate in supplier audits.
- Develop and maintain a detailed understanding of our products and related understanding of existing designs and functionality.
- Perform all other duties as assigned.
Education and Experience:
- Bachelor’s degree in Electrical and /or Mechanical Engineering or similar technical field.3 -5 years related quality experience in a manufacturing environment.
- Knowledge of quality system methodologies including 8D, Lean, 5 Why’s, Pareto Analysis, Six Sigma, 8-D.
- Knowledge of ISO 9001:2015 or ISO13485 and other recognized international quality system standards.
- Working knowledge of domestic and international regulatory and compliance schemes: UL, IEC, CE, GSA, CSA, FCC, CB Scheme, CE Directives (LVD, EMC, RoHS, REACH, CA65, Energy Efficiency).
- Ability to read mechanical drawings and prints. Knowledge of machining, sheet metal fabrication, and assembly practices.
- Must work well with diverse groups of people and be able to function independently or collaboratively in a team setting.
- Strong problem-solving skills.
- Strong organizational skills.
- Project management skills.
- Attention to detail.
- Strong written and verbal communication skills.
- Advanced computer skills using Microsoft Office applications.
- Must have a valid driver’s license in good standing and the ability to travel.
How to apply?
Send your CV to David Mitchell at email@example.com