Quality Engineer/Inspector

MillenniumSoft Inc; Louisville (CO); On-site; USD 42,000 - 52,000; Full time

Job summary

MillenniumSoft Inc. is seeking a Senior-Level Quality Engineer/Inspector for a 12-month contract in Louisville, CO. The role focuses on end-to-end medical product testing, with responsibilities spanning test planning, verification, validation, and compliance to SOPs and regulatory standards.

Candidates should have a BS in engineering, 4+ years of related experience, and proficiency with measurement tools such as calipers and micrometers, plus traceability and root-cause analysis capabilities.

Qualifications

• BS in an engineering discipline preferred.
• 4+ years of related testing experience in medical device or regulated environment.
• Experience with end-to-end product testing, requirements traceability, and test plans.

Responsibilities

• Perform testing in conformance with SOPs, regulations, and standards.
• Analyze results, determine disposition of products, and identify nonconformances.
• Develop test plans, manage requirements traceability, and support test automation.

Skills

Test management

Test method development

Verification

Validation

Cross-functional collaboration

Education

BS in engineering discipline

Tools

Calipers

Micrometers

Gage blocks

RAM optic

Job description

Level Of Experience: Senior Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) Mon - Fri 9AM - 5PM

Position : Quality Engineer/Inspector

Location : Louisville, Colorado

Duration : 12 Months

Total Hours/week : 40.00
pay rate-$20-25/hr

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Senior Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) Mon - Fri 9AM - 5PM

Education Requirements

• BS in an engineering discipline (Computer Science, Electrical Engineering, et al.) is preferred.

Job Description

We’re looking for a test engineering professional with end-to-end medical product testing experience.
The candidate should have a mix of relevant skills including, but not limiting to: test management, test method development, verification, validation, and ideally have participated in design and manufacturing activities.
They will need to work with different cross-functional development and testing groups to ensure project success by developing test plans and regression analyses, managing test requirements including requirements traceability, ensuring requirements coverage, and providing integration/system testing and root-cause analysis

Responsibilities

• Responsible for the efficient and effective performance of testing in conformance with regulations and standards.
• Responsibilities include inspection, analysis of results, determining final disposition of some product and detecting nonconforming conditions.
• Works within clearly defined SOPs and/or scientific methods.
• Adheres to quality guidelines.
• Complies with regulations and standards. Identifies basic non-compliance within regulations and standards.
• Maintains appropriate licenses / training / certifications, as needed. 4+ years of Experience.
• Able to use standard measuring equipment including calipers, Random-Access memory (RAM) optic, micrometers, pin gauges, gage blocks, etc.
• Previous experience participating in continuous improvement activities.
• Demonstrated understanding in the use of calibrated equipment and ability to follow equipment maintenance repair procedures.