Job Details

SMC Ltd. was developed around a commitment to its people and customers. This continued as a global leader in contract manufacturing for medical device, diagnostics and drug delivery companies.

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.

This position is responsible for the execution of Quality Engineering deliverables during new product development phase and launching of robust manufacturing processes that support SMC Ltd. quality system. This position will evaluate and recommend opportunities for improvements in key measurement areas including customer complaints, scrap, cost of quality, and Parts Per Million ("PPM") internal and external.

Specific duties include:

• Lead new projects:
  1. Lead new product launches with Measurement System Analysis (MSA), tolerance and GD&T reviews, FMEA, control plans, FAI, and DOE input.
  2. Manage time to meet goals of project with little input from outside forces or upper management.
  3. Lead quality assurance items for new product development projects involving multiple systems (injection molding, automation, multiple sub - assemblies, multiple parts, new processes to the company, new technologies to site, etc.).
  4. Develop inspection instructions and techniques to train the quality inspectors.
  5. Oversee DMR (Device Master Records) control for all new product launches.
  6. Work with Program Managers to write and implement Engineering Change Orders.
  7. Perform Root Cause Analysis for customer SCARs and complaints, utilize quality tools (5 whys, ishikawa, 8D, Is and Is Not, etc.), and determine test methods to establish cause and correction.

• Review existing production:
  1. Utilize the NCR systems to facilitate improvements. Trend analysis of repeat non-conformances to generate a pareto chart and target items for continuous improvement projects.
  2. Manage corrective action (CAPA) process in accordance with relevant ISO requirements. Act as CAPA champion for CAPA execution, team coordination, customer communication and updates, as well as monitoring through VoE to close.
  3. Improve manufacturing systems by implementing the best-established practices when documenting and developing a new process.
  4. Subject matter expertise in reading and interpreting of technical drawings.
  5. Create and Review Validation Master Plans (VMP) and Advanced Quality Planning (AQP) to evaluate quality standards by identifying risks associated in QMS and process validation.

• Reporting:
  1. Ensure quality planning, non-conforming materials, continuous improvement, weekly meetings, corrective/preventive actions, audit activities, etc.
  2. Act as lead auditor.

• Continuous improvement:
  1. Definition of systems for knowledge transfer / plans to bring colleagues or operations up to speed on processes or procedures.
  2. Lead Lean Projects for waste elimination.
  3. Work with colleagues and supervisors to develop validation protocols; with customer input, monitor execution and develop completion reports for approval by direct manager.

Job Requirements:

Requires a Master's degree in Mechanical Engineering or a related field and two years of experience; or a Bachelor's degree in Mechanical Engineering or a related field and five years of progressive, post-bachelor's experience.

Experience must include:

• Work as a project manager for quality action items for customer projects within new product development and sustaining production. Be the main point of contact for internal continuous improvement projects.

• Experience in framing up and challenging an inspection method by running a Gage R&R or TMV.

• Experience analyzing a population of data from a critical to quality inspection variable dimension to calculate the CpK/Ppk values.

• Experience with IQ, OQ, PQ validation/qualifications and strategy for new product development and sustain production changes.

• Experience with metrology equipment to inspect parts with traditional hand tools (calipers, micrometer, pin gauges, height gauge, and drop gauge). Writing programs, running and troubleshooting an optical CMM with laser and touch probe inspections.

• Experience using Minitab to calculate CpK, PpK, run DoE analysis, and Gauge R&R analysis.

Must have a Certified Quality Engineer certificate from the American Society for Quality Excellence.

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.

Annual Salary $129,500

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