Supplier Quality Engineer

Cepheid - US
Job Location: 
Job Description: 

The Supplier Quality Engineer will be responsible for supplier quality engineering activities. Primary responsibility will be to handle supplier quality engineering duties associated with our consumable plastics vendors including developing positive relationships and interfacing with suppliers, engineering, manufacturing and sourcing to drive quality improvements.

Supplier Production and Process Controls

- Understand and apply the manufacturing quality toolset including PFMEA, IQ, OQ, PQ, GR&R/measurement system analysis, control plans, process verification/validation plans, validation protocol development, Cpk, Cp, SPC, hard gauging applications, computer-based inspection methods, operator work
- instructions, DOE, process data analysis, and DMAIC.
- Participate in internal audits and supplier evaluations. Define and establish needed quality initiatives. Develop quality system procedures through cross-functional teams.
- Work with product support teams, engineering and others on component quality issues and supplier initiatives.
- Direct vendor interactions including travel to supplier sites.
- Assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution. Develop control plans that identify inspection characteristics, gauging techniques, and sampling requirements. Work with manufacturing sites to resolve conflicts and recommend revisions as required.
- Support the applicable site Quality System

Design Controls/Quality System

- Participate in development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations.

Engineering Drawings/Specifications (GD&T)

- Review drawings to evaluate quality requirements including correct application of geometric dimensioning and tolerancing (GD&T), proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Review and approve engineering change orders. Review product verification and validation plans and approve reports.

- Bachelor's Degree in mechanical engineering, biomedical engineering (or other applicable technical degree) or related discipline and a minimum of five
- to seven (5 to 7) years related experience OR
- Master's degree in mechanical engineering, biomedical engineering (or other applicable technical degree) or related discipline and a minimum of three to five (3 to 5) years related experience.
- Strong background and experience in plastic injection molding and tool development and qualification.
- Experience in the application of production and process controls including process validation, process control plans and statistical process control.
- Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
- Experience representing their department during quality system audits.
- Superior communication skills, both oral and written.
- Ability to work effectively in a team environment and build strong working relationships.
- Ability to constructively challenge concerns and engage in transparent conversations.
- Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
- Foster an environment that values diversity and inclusion.
- Strong attention to detail. Ability to successfully balance and prioritize multiple on-going projects/tasks (Project Management skills).
- High degree of initiative and self motivation.
- Strong analytical and problem-solving skills.
- Proficient with Microsoft Office (Word, Excel, PowerPoint).

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