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Senior Quality Assurance Technician

2 weeks ago

Berlin CT, United States TOMZ Manufacturing Corp Full time
Join Our Quality Vanguard as a Senior Quality Assurance Technician

At TOMZ, we pride ourselves on crafting impeccable medical device components through precision metal machining. If you're a meticulous professional with a knack for maintaining standards and guiding teams, your expertise could find a perfect home here.

Your Critical Role

Reporting directly to our quality leadership, your primary mission is to champion our quality control processes. Expect to immerse yourself in the dynamics of ISO 13485 standards, ensuring each component produced meets the highest benchmarks of excellence.

Core Responsibilities
  • Head up and mentor a team of skilled Quality Control personnel. Provide strategic direction and oversight to align workloads with organizational targets.
  • Masterfully inspect machined components using an assortment of tools, including microscopes, calipers, and micrometers.
  • Generate and manage comprehensive documentation that adheres to Quality Inspection standards.
  • Ensure that Device History Records reflect the utmost conformity with the Device Master Record.
  • Leverage ERP and QMS systems to reinforce record integrity and traceability.
  • Participate in and promote continuous improvement initiatives aligned with best practices and regulatory standards.
  • Spearhead critical inspections — from Incoming to Final — and manage nonconformities effectively.
  • Adapt seamlessly to varied quality requirements across different production lines while supporting department objectives.
  • Conduct and oversee nuanced inspections using advanced technologies like comparators and CMM systems.
Who You Are
  • An analytical thinker with proficiency in reading technical blueprints and specifications.
  • An advocate for accuracy, showcasing attention to detail in all tasks.
  • Adept in software tools like Microsoft Office and comfortable operating independently or in collaboration with others.
  • Experienced with mechanical measurement instruments, such as micrometers and calipers, underpinned by knowledge of mechanical inspection processes.
Your Background
  • Educational: A high school diploma or GED, with a preference for manufacturing or engineering disciplines.
  • Experience: 5+ years in a regulated manufacturing environment, with exposure to Class I, II, or III Medical Device production.
  • Desirable Credentials: Holding quality certification(s) such as ASQ CQT or QCI; familiar with GMP/ISO standards.
Physical Requirements
  • Capability for handling up to 50 pounds, with assistance for heavier items.
  • 20/20 vision required for precision sorting and inspections.
  • Regular exposure to elements like oil, grease, and cleaning solvents.
If quality excellence drives your professional passion, and you're eager to lead with integrity, apply to help maintain our high standards while advancing your career prospects.