Quality Engineer

IDEX•Rohnert Park, CA

13d•Onsite

About The Position

IDEX Health & Science is a manufacturer of precision fluidic devices for the scientific instrument industry, serving original equipment manufacturers and laboratory customers through a worldwide network of authorized distributors. The Quality Engineer ensures that products meet purchase specifications, design requirements, and quality and reliability requirements. The role calls for ownership, flexibility, positive collaboration, and contribution to a shared quality culture. The Quality Engineer works across the organization and with customers, suppliers, Engineering, Manufacturing Engineering, and Operations to maintain compliance, improve products and processes, qualify parts and suppliers, and support new product development. The position is based in Rohnert Park, California, and requires approximately 20% domestic and international travel.

Requirements

Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a relevant field preferred.
At least 3 to 5 years of Quality Engineering experience.
Experience with GD&T methodology.
Demonstrated experience with electronics and IPC standards, as well as metal fabrication processes.
Familiarity with FMEA, control plans, and statistical techniques.
Experience with ISO 9001 or ISO 13485, electronic workmanship standards (IPC-610/IPC-620), and electrostatic discharge standards (Mil-Std-1686, ANSI 20.20, or JES D625-6).
Understanding of quality metrics, process characterization and mapping, product quality, reliability management, improvement techniques, Design for Manufacturing, Lean Manufacturing, VSM, Six Sigma, and continuous process improvement.
Excellent written and oral English communication skills.
Proficiency with Microsoft Office applications, including Word, Excel, Outlook, PowerPoint, and Access.
Ability to travel approximately 20% domestically and internationally.
Ability to work collaboratively, take ownership, facilitate processes, and achieve closed-loop outcomes.

Nice To Haves

American Society for Quality Certified Quality Engineer (CQE) certification desired.
Internal auditing experience; ASQ Certified Quality Auditor (CQA) or Certified Biomedical Auditor (CBA) is a plus.
Knowledge and use of Minitab and statistical process control, including SPC and CPK.
Familiarity with ERP and document-control systems such as Oracle, JDE, Adobe Acrobat, and AutoCAD.

Responsibilities

Lead, collaborate, facilitate, and support organizational needs while fostering a positive work environment and shared quality culture.
Take initiative, own assigned work, and follow through; communicate openly at all levels and contribute to team and company goals.
Assure compliance with ISO 9001, company policies, and regulatory requirements.
Assure customer and supplier quality performance.
Collaborate with Engineering and Manufacturing Engineering on the design, pre-production, and release of new products.
Develop and implement IQ/OQ and PQ protocols.
Support robotics design, planning, and automation controls.
Qualify parts used in the development of new products.
Coordinate first-article and supplier-part qualification approvals between IDEX and suppliers.
Implement quality planning, control plans, FMEA, inspection methodologies, and root-cause analysis.
Work with Operations and Engineering to improve efficiency, manufacturing processes, and product quality and reliability.
Develop and manage KPIs, databases, and countermeasures for continuous improvement.
Participate in Material Review Board activities and provide feedback to suppliers.
Analyze root causes and implement corrective actions for process-related concerns.
Participate in supplier development, process-capability work, technical gap analysis, qualification, and monitoring of quality and on-time delivery.
Revise internal procedures as applicable to implement a customer and supplier quality management program.
Lead or participate in continual-improvement activities, including 5S, Kaizen, and Lean methods.
Perform other duties as assigned.