Quality Engineer I or II

SMC Ltd; Santa Rosa (CA); On-site; USD 75,000 - 100,000; Full time

Job summary

SMC Ltd in Santa Rosa, CA, is seeking a Quality Engineer to support the quality system and drive improvements across measurement, inspection, and process controls. You will lead MSAs, GD&T reviews, FMEA, control plans, FAI and DOE input, and provide cross-functional technical support to program management.

Responsibilities include SPC monitoring, first article review, NCRs/CAPA coordination, DMR control, root cause analysis, and collaboration with suppliers and customers to prevent recurrence.

Qualifications

• Bachelor of Science in Engineering or similar technical discipline.
• ASQ CQT or CQE certification is desirable.
• Experience with metrology equipment and SPC.
• Strong written and verbal communication and cross-functional collaboration.

Responsibilities

• Lead new product launches with MSA, GD&T reviews, FMEA, control plans, FAI and DOE input.
• Identify critical variables and attributes and perform first article sampling.
• Conduct statistical analysis and SPC dimensional monitoring for production.
• Prepare validation quotes and provide technical support to Program Management.
• Oversee DMR control for new launches and implement Engineering Change Orders.
• Lead CAPA process and assist ISO 13485 and FDA audits as needed.
• Coordinate root cause analysis, corrective actions, and supplier/customer interfaces.

Skills

Analytical thinking

Problem solving

Team collaboration

Communication

Education

Bachelor of Science in Engineering

ASQ CQT/CQE

Tools

Solidworks

Minitab

Microsoft Office

Job description

Salary Range: $75,000.00 To $100,000.00 Annually

Located in beautiful Santa Rosa, CA, SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

In the role of a Quality Engineer you will be responsible for deliverables to support SMC’s 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 is expected to perform other related duties in conjunction with other employees and departments contributing to the overall team effort, efficient process, and safe working environment. This position includes many essential components necessary for successful and efficient manufacturing, and as such, shares full responsibility for the final product delivered to the customer.

Performance will be based on execution of work, ability to meet projected timeline and production support requirements, ability to maintain expected levels of quality and control, communication, continual improvement, the ability to work in a team environment, and successfully coordinate the operations of multiple departments to achieve success.

Essential Job Duties and Responsibilities:

• 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;


• 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.


• 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.


• 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.


• 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. Essential Qualifications:


• 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


• Solidworks Modeling Software Experience


• Experience with the following:
  
  
  
  • Various metrology equipment.
  
  
  • Microsoft Office suite
  
  
  • Statistical process control
  
  
  
  

Desirable Qualifications:

• Medical Device manufacturer background


• Experience using Minitab Software for SPC, DOE, etc.


• Communication, Oral - Ability to communicate effectively with others verbally.


• Communication, Written - Ability to communicate in writing clearly and concisely.


• Detail Oriented - Ability to pay attention to the minute details of a project or task.


• Time Management - Ability to utilize the available time to organize and complete work within given deadlines.


• Working Under Pressure - Ability to complete assigned tasks under stressful situations.


• Reliability - The trait of being dependable and trustworthy.


• Previous high-volume manufacturing experience.


• Experience within the medical device industry.


• Previous experience with lean manufacturing concepts.

ADA Requirements:

• Medium work: Exerting up to 50 pounds of force occasionally and/or a negligible amount of force constantly to move objects.


• Ability to work for extended periods sitting and looking at computer while completing repetitive motions to include substantial movements (motions) of the wrists, hands, and/or fingers.


• Close visual acuity to perform an activity such as preparing and analyzing data and figures; reviewing detailed information; viewing a computer terminal; and expansive reading.


• The ability to manage a number of projects at one time with frequent interruptions and tight deadlines.


• Stooping, Kneeling, Crouching, Crawling, Reaching, Standing, Walking, Pushing, Pulling, Lifting, Fingering, Grasping, Feeling, Talking, and Hearing.

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.