Title: Medical Device Quality Engineer

Title: Medical Device Quality Engineer

Location: Lafayette, CO (Onsite)

Type: W2 contract.

We have Mid-level and senior level openings for below positions.

6+ Years design experience in Medical Device industry, Class III experience helpful, but not required Kaizen Lean Six Sigma Certified Medical device industry experience Experience in Complaint Handling, Regulatory Reporting, FCA, FDA, and/or CAPA PMP Certification or other formal Project Management training and experience Program Management/Project Management.

Top 3 technical  skills that you are required for the role:

1.         CAPA

2.         Medical device risk management

3.         Compliance effective oversight

Education Required: Bachelor’s Degree in Engineering, Science or technical field with 6+ years of work experience in Engineering and/or Quality.

Job description:

Responsibilities may include the following and other duties may be assigned.

A representative for the Released Product Management (RPM) Design Quality team on projects that address day-to-day quality issues of the market-released products.

Compliance effective oversight with the RPM activities per the applicable Standard Operating Procedures (SOP's) and External Standards as part of the process.

Contribute and lead activities during the following activities:

Risk analysis, including product risk assessment ownership, key stakeholder to various Failure Mode and Effects Analysis, and assessing specific product issues for impact to patient and/or user safety and product quality

Drawing and specification reviews

Verification and Validation testing and reporting

Product performance reviews

Test method validation

DHF audits

Mechanical drawing review and approval per ASTM-14.5Y.

Technical problem-solving compiles data and prepares reports on findings to identify trends proposes corrective action as needed.

Collaborates with RPM project cross-functional team to ensure quality standards are in place.

Specialize in RPM risk management, test method validation, and equipment calibration/qualification/validation.