Senior Compliance and Quality Engineer

Job Location: Santa Clara, CA.

Job Term: Full-Time

The Opportunity:

We are seeking an experienced Sr. Compliance and Quality Engineer to play a critical role in helping the enterprise to successfully sustain formal ISO 9001:2015 Certification, supporting Quality assurance, monitor and drive actions with stakeholders for regulatory compliance in ROHS, WEEE,CE and CSA while driving and guiding continuous improvement. This position is ideal for one who really enjoys the challenge to develop, implement and sustain cross-functional processes designed to achieve maximum performance efficiency and superior product and service quality. Reporting to the Sr. Quality Director, the incumbent will have the opportunity to interact with Company employees at all levels while helping to refine a robust and enduring Quality Management System. Success will serve to help accelerate business growth by developing a strategically competitive edge through superior quality and customer satisfaction. 

 

Key Responsibilities:

  • Participate or coordinate QMS activities such Non-conformance process, CAPA process, 8Ds.
  • Manage the Corrective Action and continual improvement processes. Work collaboratively with representatives from all functions to identify and as needed lead team-based Kaizen improvement initiatives within Operations and other functional areas.
  • Monitor, measure and analyze process(es) performance on a continual basis to identify data-driven opportunities for improvement.
  • Create, update and/or revise Standard Operating Procedures (SOPs).
  • Provides input and monitors of Customer field reports.
  • Participate in activities related to ISO 9001 compliance such internal audits and external audits preparation, monitor non conformances and drive for improvement on recurrent findings.
  • Provide support in preparation and actions related to Quality management systems reviews.
  • Monitor and drive actions with proper departments for our continuous compliance with product regulations such ROHS, REACH, WEEE, CE marking, CSA and others as needed.
  • Coach and develop extended team members as necessary to assure a common understanding of Quality Management processes.
  • Deliver and execute Quality System related activities against the established plan and due dates. .
  • Establish KPI tracking and monitor deliverables critical to the department and business.

 

Minimum Qualifications:

  • Minimum 5 years of related Quality assurance engineering experience on a regulated environment in a high technology product manufacturing environment.
  • Minimum of Bachelor of Science degree in Mechanical Engineering, Optical Engineering or Industrial engineering. (Master’s degree in these fields is preferred).
  • Demonstrated experience with and proficiency in applying and successfully achieving significant results using the following quality improvement tools: Lean Manufacturing, Process Auditing, Design/Process Failure Modes & Effects Analysis (d/pFMEA), Measurement System Analysis-Gage R & R, Root Cause Analysis (Ishikawa diagramming), 5-Whys, 8D Problem Solving, Risk Assessments, etc.
  • Computer proficiency: MS Excel, PPT, Word, Access DB, Visio, MS Project, Arena, NetSuite, etc. Must be meticulous, possess strong organizational and problem-solving skills within a team environment.
  • Experience with and working knowledge of CE, Directive (EU) 2015/863 (RoHS 3), WEEE (Directive 2012/19/EU) and REACH compliance would be a plus.

 

Preferred Additional Qualifications:

  • Demonstrated experience in applying and successfully achieving significant results using the following quality improvement tools: Six Sigma (DFSS, DMAIC), Statistical Process Control, Process Mapping and Activity Value Analysis, SIPOC, Process Capability Analysis, Design of Experiments (DOE) Planning, Implementation and Analysis, etc.
  • Experience with spectroscopy/laser-based optical instruments, mass spectrometry or other trace gas analyzers would be a plus.
  • ASQ Certifications: CQE, CQA.

 

About Picarro:

Picarro is pioneering a unique confluence of hardware, software and cloud-based computing unlike anything being done today. By manufacturing the precision instruments at the core of this technology as well as developing the algorithms that enable cogent information to be derived from the data, we are transforming how world-class scientific, industrial and regulatory compliance measurements are made, and more importantly, who makes them.

 

Infrared optical spectroscopy is a proven technology for delivering precise, real-time measurement of the constituents in a gas stream with high sensitivity and selectivity. Recent developments in laser technology allow for a very significant increase in the number of species that can be measured simultaneously, leading to an unprecedented increase in the amount of information that can be collected and to corresponding challenges in extracting information from the results.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, gender identity, social orientation, nor on the basis of disability.

Posted positions are not open to third party recruiters/agencies and unsolicited resume submissions will be considered free referrals.

 

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Picarro, Inc. at disabilityassistance@picarro.com for assistance.

 

Posted positions are not open to third party recruiters/agencies and unsolicited resume submissions will be considered free referrals.

 

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