Tecomet, Inc · 8 hours ago
Sr. Quality Engineer
Tecomet, Inc is a company focused on continuous improvement and customer-driven innovation. The Sr. Quality Engineer will ensure compliance with quality engineering standards and support manufacturing operations while meeting financial and performance metrics.
ManufacturingPrecious Metals
Responsibilities
Maintaining applicable quality system, environmental, and FDA requirements/certifications
Facilitate operator owned quality program
Supporting the MRB and RMA processes
Work with team members and support manufacturing/operations to solve quality, cost and schedule issues
Prepare FMEA’s, controls plans, quality plans, PPAP
Coordinate process validations and reduce dependence on inspection
Generating applicable quality metric reports; cost of quality, management by facts
Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses
Special projects as assigned by quality management
Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations
Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques
Applies statistical and Six Sigma concepts and techniques
Works with Internal and External Customers
Participates in audits and inspections
Writing and maintaining quality related work instructions and procedures
Qualification
Required
Bachelor's Degree in Quality or related field and/or a combination of education, certifications and experience will be considered
Maintaining applicable quality system, environmental, and FDA requirements/certifications
Facilitate operator owned quality program
Supporting the MRB and RMA processes
Work with team members and support manufacturing/operations to solve quality, cost and schedule issues
Prepare FMEA's, controls plans, quality plans, PPAP
Coordinate process validations and reduce dependence on inspection
Generating applicable quality metric reports; cost of quality, management by facts
Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses
Special projects as assigned by quality management
Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations
Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements, and standard problem-solving techniques
Applies statistical and Six Sigma concepts and techniques
Works with Internal and External Customers
Participates in audits and inspections
Writing and maintaining quality related work instructions and procedures
Manufacturing operations - forging and/or machining
Measuring devices
Quality Systems
Regulations - FDA, GMP and ISO
Blueprint reading
GD&T
Metrology
Problem solving and 8D
Math skills (algebra, trigonometry) skills
Microsoft office (Word, Excel, Outlook, PowerPoint)
Minitab
Preferred
ASQ CQE or CMQ/QE preferred
4 years' experience in quality within medical device manufacturing industry preferred
ISO 13485, FDA 820 and customer interaction experience preferred
Company
Tecomet, Inc
Tecomet develops proven, full-spectrum scalable manufacturing solutions for leading medical device technology, aerospace, and defense companies for whom exceptional quality is critical.
H1B Sponsorship
Tecomet, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2017-05-01Acquired
Leadership Team
Recent News
GlobeNewswire
2026-01-16
2026-01-16
2025-11-07
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