- Support projects from product inception through launch and maintenance.
- Ensure compliance with design controls and regulatory requirements.
- Apply quality engineering tools such as:
- Root Cause Analysis
- FMEA
- Risk Mitigation
- Process Validation
- DOE (Design of Experiments)
- Measurement Systems Analysis
- Sampling Plans
- Control Plans
- Provide quality engineering guidance to cross-functional project teams.
- Approve validation protocols, reports, and change control documentation.
- Represent Site Quality on product development and sustaining engineering teams.
- Collaborate with quality management, operations, suppliers, and internal stakeholders.
- Apply sound quality assurance principles and moderate-level technical knowledge to resolve routine to moderately complex issues.
- Determine resource needs for assigned initiatives and support plant-level product projects.
- Bachelor's degree in Engineering (Industrial, Mechanical, or related field).
- 3+ years of Quality Engineering experience, including validation responsibilities.
- Strong knowledge of validation processes in medical devices.
- Demonstrated experience with statistical analysis and structured problem-solving methodologies.
- Proficiency in:
- Minitab (or similar statistical software)
- Microsoft Word, Excel, and Project
- Strong understanding of failure analysis, test methods, and engineering tolerances.
- Knowledge of regulatory standards including:
- 21 CFR 820
- 21 CFR 210 & 211
- ISO 13485
- Six Sigma Certification (preferred)
- ASQ Certified Quality Engineer (CQE)
- Certified Quality Auditor (CQA)
- Project Management experience
- Excellent verbal, written, and interpersonal communication skills
-
Title: Quality Engineer II · Location: Holdrege NE 68949 · Duration: FTE/Direct Hire · Type: Onsite Only · Job Description: · As directed by the Quality Engineering Leader, the Quality Engineer II is accountable for supporting new product development and/or product sustaining act ...
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Quality Engineer II - Holdrege - Intellectt Inc
Description
Immediate Hiring for Quality Engineer II Holdrege, NE (Onsite Only) - Full time
Shift: 1st Shift
Hours: 40 hours/week (Overtime as approved by manager)
Salary Range: $65,000 – $75,000
Position Summary
Reporting to the Quality Engineering Leader, the Quality Engineer II supports both New Product Development (NPD) and Sustaining Engineering activities for medical devices. This role ensures compliance with corporate quality policies, design control requirements, and regulatory standards while driving continuous improvement across operational processes.
The Quality Engineer II plays a key role in product lifecycle activities—from concept through launch and post-market support—ensuring product quality, process control, and regulatory compliance.
Key Responsibilities
New Product Development (NPD)
Sustaining Engineering
General Responsibilities
Basic Qualifications
Preferred Qualifications
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Quality Engineer
Only for registered members Holdrege
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Quality Engineer II
Only for registered members Holdrege
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Quality Engineer II
Only for registered members Holdrege
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Quality Engineer II
Only for registered members Holdrege
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Quality Engineer II
Only for registered members Holdrege
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Quality Engineer II
Only for registered members Holdrege
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Quality Engineer II
Only for registered members USA NE - Holdrege
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Quality Engineer II
Only for registered members Holdrege, NE
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Manufacturing Quality Engineer
Only for registered members Minden
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Manufacturing Quality Engineer
Only for registered members Minden
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Plant Quality Engineer
Only for registered members Kearney, NE
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Manufacturing Quality Engineer
Only for registered members Minden, NE
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Manager
Only for registered members Holdrege
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Production Supervisor
Only for registered members Holdrege
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Electrical Mechanical Technician B Shift
Only for registered members Holdrege
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Electrical Engineer IV
Only for registered members Holdrege, NE
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Quality/Microbiology Technician II 1st Shift
Full time Only for registered members Holdrege
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Setup Operator
Only for registered members Holdrege
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Electrical Mechanical Technician B Shift
Only for registered members Holdrege, NE
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08 Setup Operator C Shift
Only for registered members Holdrege