Quality Engineer

You are a Quality Engineer and you will be responsible for deliverables to support our quality system. Evaluate and recommend opportunities for improvements in key measurement areas (customer complaints, scrap, cost of quality, PPM Internal/External). Provide customer support including the extended enterprise (suppliers) targeting permanent problem resolution and implementation of proactive preventative measures to prevent recurrence. Production support of sustaining programs will include maintaining inspection methods, troubleshooting support for quality inspectors, and data analysis.

This position pays: $97,000 - $135,000

Location: Onsite, Santa Rosa, CA

What you will be doing:

Reviews new projects and sees to the following as applicable: Lead new product launches with Measurement System Analysis (MSA), tolerance and GD&T reviews, FMEA, control plans, FAI and DOE input. Identification of critical variables and attributes; First article sampling and reporting; Develops Inspection Instructions/Techniques Statistical analysis if required; SPC dimensional monitoring for production; Preparation for quality assurance of initial trial and subsequent production; Prepare Validation Quote Analysis as needed. Provide technical support to Program Management Department. Oversee DMR (Device Master Records) control for all new product launches. Work with Program Managers to write and implement Engineering Change Orders.

Reviews existing production: Identifies opportunities for improvement to process and product; Provides applicable training; Utilizes the NCR systems to facilitate improvements. Assist in corrective action (CAPA) process in accordance with relevant ISO requirements.

Reporting: Interfaces with customers: Quality Planning, Non-Conforming Materials, Continuous Improvement, Weekly Meetings, Corrective/Preventive Actions, Audit Activities, etc. Supports the ISO 13485 Business Management System through Internal Auditing. Assist with third party and FDA quality audits as needed. Provide expertise in the Quality Assurance area on new projects and prepare written reports and documentation for internal and/or external use as required or assigned.

Continuous Improvement: Coordinates implementation of product and process improvements; Conducts investigation, root cause analysis and corrective actions; Monitors and expedites the closure of corrective/preventive actions resulting from customer complaints, safety issues, management review, non-conforming product and staff generated. Participates and Leads Lean Projects for waste elimination.

Standards: Develops, maintains and updates Procedures, Work Instructions, and Forms. Responsible for following documented procedures established by the SMC Ltd. Quality Management System while adhering to all company policies, work environment and safety requirements.

What you bring:

A Bachelor of Science degree in Engineering or similar technical discipline preferred.

Excellent planning, leadership, and client relationship skills

Excellent interpersonal communication and writing skills

ASQ, CQT/CQE

CMM/MicroVu Programming Experience

Solidworks Modeling Software Experience

Gage R&R, CpK/PpK studies,

IQ, OQ, PQ validation/qualifications, DoE analysis… etc.

Experience with the following:

Various metrology equipment.

Microsoft Office suite

Statistical process control

Ability to read, write and speak English:

Injection molding background

Medical Device manufacturer background

Experience using Minitab Software for SPC, DOE, etc.