Quality Engineer; Medical Device

Position: Quality Engineer (Medical Device)

Quality Engineer (Medical Device)

Company:

Intertech Medical LLC

Primary

Location:

4525 Kingston St, Denver, CO 80239 USA

Workplace Type:

On-site

Employment Type:

Salaried | Full-Time

Function:

Quality

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

Main

Duties & Responsibilities

Job Summary:

The Quality Engineer collaborates closely with customers and engineering teams to define product requirements, ensuring seamless communication of these specifications to production. They oversee quality system performance, investigate concerns, and implement preventive actions and process improvements. Additionally, they address daily quality issues, escalating them when necessary to maintain high standards.

Key Responsibilities

• Support Engineering during new product introductions and launches
• Perform Validation activities, including First Articles and Capability analysis
• Perform Product and Process Risk Assessments
• Audit, qualify and optimize quality plans and manufacturing processes
• Investigate customer issues and problems as assigned by Quality Manager
• Issue and manage deviations from established processes
• Track, review, and approve Corrective and Preventative Actions (CAPA) and Non-Conformance Reports (NCRs)
• Address day to day quality problems and troubleshoot manufacturing problems
• Maintain quality plans for new products, and revise quality plans for existing products
• Drive Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) throughout the company
• Implement process improvements to prevent defects and improve efficiency
• Assure statistical controls and sampling methods for inspection and testing are created and complied with
• Maintain records to demonstrate quality system effectiveness (including scrap over standard and material certificates)
• Monitor Overall Equipment Effectiveness (OEE) quality by shift
• Perform internal ISO auditing
• Report quality system results to management (including complaints analysis)
• Maintain up-to-date calibrated equipment in use for inspection by the Quality Assurance (QA) Lab
• Administer quality system documentation (including procedures, forms, and quality plans)
• Perform housekeeping and safety audits
• Provide training and testing for departmental personnel as it relates to their involvement in the quality process
• Perform duties in accordance with Intertech’s QMS, ISO, and safety regulations
• Must be able to discern color differences (No color blindness)
• Must be able to detect defects in molded components by passing a Defect Awareness Test

On-Site:

This role is required to be on-site 5 days at the Denver, CO location.

Qualifications

• 4-year BS degree or equivalent experience
• Project management experience
• Word processing, spreadsheet, and presentation software such as MS Word, Excel, PowerPoint.

Compensation

In compliance with all states and cities requiring transparency of pay, the expected pay range for this position is $67,400 - $82,000.

Compensation can vary depending on several factors, including a candidate's qualifications, skills, experience, competencies, and geographic location. Some roles may qualify for extra incentives like equity, commissions, or other variable performance-related bonuses. Further details will be provided by our recruiting team during the interview process.

Benefits

Benefit offerings include Medical Insurance and Prescription Drugs, Dental Insurance, Vision Insurance, Flexible Spending Accounts, Life Insurance, Short-Term Disability, Long-Term Disability Insurance (for eligible employees), Employee Assistance Plan (EAP), Paid Time Off (may include vacation and sick time), Retirement Program, and Other Voluntary Benefits.

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