Senior Quality Engineer

Join our team in Berlin, CT!! 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.

Essential Functions

• 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.
• Additional responsibilities as outlined in the full job description.

Qualifications:

Education

• 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 experience including CMM and/or Vision System programming. (10+ years of experience in Quality Engineering or similar discipline will be considered in lieu of a degree

Experience

• Minimum of 7+ years’ experience in a regulated manufacturing environment.
• Prior experience as a Lead on a Program or with a customer. Prior experience mentoring a junior associate.

Qualifications

• 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.

Preferred Skills

• ASQ CQE or CRE.
• Expertise in 3D modeling Solid Works, Unigraphics, Mastercam, Solid Edge, etc.
• Six Sigma Green or Black belt.
• Certifications in DMIS programming are preferred.
• Knowledge and experience with external standards: ISO 9000/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).

Travel Requirements

• Travel outside the workplace is possible for up to 10% of the year.
• Travel may include multiple overnight stays and may occasionally require weekend commitments

TOMZ Corporation is an Equal Opportunity Employer