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: 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 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.
- Bachelor's 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 Master's degree in Mechanical Engineering, Biomedical Engineering (or other applicable technical degree) or related discipline and a minimum of five (5) years related experience.
- 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 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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