Quality Engineer I jobs in United States
cer-icon
Apply on Employer Site
company-logo

Tecomet, Inc · 4 hours ago

Quality Engineer I

Tecomet, Inc is a company focused on quality engineering and continuous improvement. The Quality Engineer I will ensure compliance with internal and external customer requirements, maintaining quality systems, and supporting manufacturing operations to resolve quality issues.

ManufacturingPrecious Metals
check
H1B Sponsor Likelynote

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
Standard problem-solving techniques
Applies statistical and Six Sigma concepts and techniques
Works with Internal and External Customers
Participates in audits and inspections

Qualification

Quality SystemsFDA regulationsISO 13485Statistical techniquesMinitabProblem solvingBlueprint readingGD&TMath skillsMicrosoft Office

Required

Bachelor's Degree in Engineer or related field
Minimum of 4 years' experience within the Medical Device Industry
Certification (ASQ CQE or CMQ/QE)
Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations
Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements
Standard problem-solving techniques
Applies statistical and Six Sigma concepts and techniques
Works with Internal and External Customers
Participates in audits and inspections

Preferred

ASQ CQE or CMQ/QE preferred
2 years' experience in quality within medical device manufacturing industry preferred
ISO 13485, FDA 820 and customer interaction experience preferred

Company

Tecomet, Inc

twittertwittertwitter
company-logo
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 Stage
Total Funding
unknown
2017-05-01Acquired

Leadership Team

leader-logo
Jason Brasile
Executive Vice President & CFO
linkedin
leader-logo
Jenifer L. Zbiegien, GPHR, CPSP
Executive Vice President & Chief HR Officer
linkedin
Company data provided by crunchbase