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Quality Engineer CA Open (J#27732)
Education: Bachelors Degree
Experience: 4 - 9 years

The Senior Quality Engineer will be responsible for concurrent quality engineering activities. Primary responsibility will be
to handle quality engineering duties associated with on-going manufacturing and production at our plastic injection
molding facility: design controls, quality planning, and establishment of appropriate manufacturing process validations and
controls and will participate in external and internal quality audits.

The essential responsibilities include:

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 mapping and data analysis,
and DMAIC.
Conduct investigations to identify root cause of problems and implement effective corrective actions. Participate in internal
audits and supplier evaluations. Defines and establishes needed quality initiatives. Develop quality system procedures
through cross-functional teams.
Create specifications and test methods, solid experience in test method validation and designing test fixtures.
Develop, troubleshoot and refine manufacturing processes and equipment.
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.
Train and coach QEs and Associate QEs. Provide training and business process expertise within and outside the quality
department. Provide support to other Global Quality projects as needed.
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.

Required Knowledge, Skills, and Abilities

Bachelors Degree in Mechanical Engineering, Biomedical Engineering (or other applicable technical degree) or related
discipline from and a minimum of seven
(7) years related experience OR Masters degree in Mechanical Engineering, Biomedical Engineering (or other applicable
technical degree) or related discipline and a minimum of five (5) years related experience.
Experience working in a high-volume injection molding environment.
Experience in the application of production and process controls including process mapping and 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.
Superior communication skills, both oral and written, including technical writing.
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 ongoing 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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