Senior Quality Engineer

The role

The Senior Quality Engineer will sustain Picarro's ISO 9001:2015-certified Quality Management System. This role involves driving improvements in product quality, process performance, and regulatory compliance in a high-technology manufacturing environment.

What you will do

• Own, support, and continually improve ISO 9001:2015-compliant processes.
• Coordinate and participate in core QMS activities including internal audits, external audit preparation, nonconformance management, CAPA, 8D investigations, and management review support.
• Lead corrective action and continual improvement initiatives.
• Monitor, measure, and analyze process performance, quality trends, customer returns, field issues, and nonconformance data.
• Create, revise, and maintain quality procedures, work instructions, forms, and records.
• Collaborate with Operations, Engineering, Supply Chain, Service, and suppliers to improve quality performance.
• Support product and process risk management activities including FMEA, control plans, risk assessments, and change evaluations.

Required qualifications

• Minimum of 5 years of related quality engineering, quality assurance, or quality systems experience in a regulated, high-technology product manufacturing environment.
• Bachelor of Science degree in Mechanical Engineering, Optical Engineering, Electromechanical Engineering, Industrial Engineering, or a related technical discipline.
• Proficiency applying quality and problem-solving tools including Lean Manufacturing, process auditing, dFMEA/pFMEA, Control plan, Measurement System Analysis, Gage R&R, root cause analysis, Ishikawa d
• Working knowledge of ISO 9001:2015 requirements, internal audit practices, corrective action systems, document control, and quality records management.
• Hands-on experience supporting supplier quality activities including supplier qualification, supplier audits, supplier corrective action requests, incoming inspection, supplier performance monitoring,
• Proficiency with business and quality systems/tools such as Microsoft Excel, PowerPoint, Word, Access, Visio, MS Project, Tableau or Power BI Data analytics, Arena, NetSuite, or equivalent platforms.
• Strong attention to detail, organizational discipline, communication skills, and problem-solving capability.
• Ability to influence cross-functional stakeholders, manage competing priorities, and drive actions to closure.

Nice to have

• Master's degree
• Experience with CE marking, Directive (EU) 2015/863 (RoHS 3), WEEE Directive 2012/19/EU, REACH, CSA, or similar product compliance requirements
• Experience applying advanced improvement methods such as Six Sigma, DFSS, DMAIC, Statistical Process Control, process mapping, activity value analysis, SIPOC, process capability analysis, and Design o
• Experience with spectroscopy, laser-based optical instruments, mass spectrometry, trace gas analyzers, capital equipment, or similar high-precision technology platforms
• ASQ certification, such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), Six Sigma Green Belt, or Six Sigma Black Belt

Benefits

• Medical, Dental, and Vision insurance
• Flexible Spending Account (FSA) and Health Savings Account (HSA) plans
• Life, Short-Term Disability, and Long-Term Disability Insurance
• Paid Time Off
• Paid Holidays
• Employee Referral Program
• 401K
• Social events (summer picnic, holiday party, team lunches, etc.)
• On-site Health & Wellness programs (fitness challenges, outdoor bootcamp, flu-shots, etc.)

About the company

Picarro is a leader in data using enhanced optical spectroscopy. Their software and hardware are designed and manufactured in Santa Clara, California and are used in over 90 countries worldwide.