Senior Quality Engineer- Lake

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QUALITY Full Time Big Lake, MN, US

Salary Range: $ To $ Annually

Join our team in Big Lake!!

Reporting to the Quality Engineering Manager this position will be responsible for the activities associated with Quality of commercial product and successful transfer of Development programs to standard production, through leadership, coaching and technical guidance of cross-functional Engineering teams. This role will be expected to provide input on, and contribute to, development and implementation of Quality System improvement strategies and approaches.

Additionally, this role will serve as a critical team member for activities associated with Quality Control and Assurance during New Product Introduction activities.

• Author and execute Manufacturing Quality Plans, Control Plans and Master Validation Plans to support New Product Introduction.
• Controls the development and updates of Risk Management files in cooperation with cross-functional engineering teams, operations, and customers.
• Authors Inspection Plans and defines process controls.
• Subject Matter expertise of precision measuring instruments and their application, including but not limited to, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
• Execution and evaluation of Test Method Validations.
• Creation of production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Review and disposition non-conformities utilizing MRB/NCR process.
• Performs process qualifications, analyzes data and initiates corrections or corrective actions as required
• Provides hands-on directions for executing Incoming, In-Process and Final Product Inspection plans.
• Support First Article Inspections.
• Support Gage calibration review, management, execution and evaluation.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues through the CAPA process.
• Interfaces with the customer and meets all defined deliverables.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
• Generate ECOs for the release of Quality Engineering documentation.
• Defines and Measures KPI’s for New Product Introduction.
• Supports the procurement and qualification of capital equipment.
• Operates and programs advanced measurement equipment including Vision Systems and CMMs.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

• Regulated manufacturing industry experience preferably Class I, II and/or III Medical Device manufacturing experience (exp: Aerospace, Defense, Pharmaceutical, etc.).
• Prior experience as a Lead on a Program or with a customer. Prior experience mentoring a junior associate.
• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (Visio, Project, Outlook, Word, Excel, and PowerPoint).
• Strong verbal and technical writing capabilities (English language).
• Expertise is statistical techniques, GD&T, process validation, and Metrology.
• Demonstrated ability to work in and lead teams through large scale projects.

• Bachelor's or higher degree in Engineering, Manufacturing, or Business discipline or equivalent of directly transferable industry work experience.
• Engineering degree and 7+ years of manufacturing quality experience including advanced metrology…