Job Description

***NO H1B/ C2Cs***

Position: Quality Engineering Manager

Location: Holdrege NE 68949

DIRECT HIRE FULL TIME

Salary: $130k – 135k annually

INPERSON INTERVIEW REQUIRED

H1B/ C2C/ VISA SPONSORSHIP: NO

Relocation Expenses/ Assistance: Yes (while not a fixed amount, support will be provided. However, this does not include home sales or comprehensive relocation services for a family of 4)

Position Summary:

The Quality Engineering Manager will lead all Quality Engineering activities and manage incoming quality issues. This role ensures that all quality-related systems at the plant are well-established and documented to deliver safe and effective products. The position is responsible for building robust technical and organizational capabilities within the quality function and ensuring compliance with applicable government regulations and quality policies and practices.

Essential Functions (include but are not limited to):

• Develop, implement, and improve production and process control strategies to meet quality management and plant objectives.
• Provide quality engineering support for product and process validation efforts.
• Participate in the Material Review Board (MRB).
• Review and approve changes to the Device Master Record.
• Review and approve qualifications, validation protocols, and final reports.
• Develop and oversee strategic quality planning initiatives.
• Lead and support quality engineering projects; drive continuous improvement activities (e.g., Lean, Root Cause Analysis, Control Plans, Six Sigma, Statistical Problem Solving).
• Manage vendor qualification and certification programs in coordination with Supply Management and Supply Quality Engineering teams.
• Ensure compliance with Client quality policies, procedures, and applicable local, state, and federal safety regulations.
• Provide leadership in team development, effective communication, and timely resolution of customer quality concerns.
• Mentor and support the professional growth of quality engineering staff.
• Establish strong working relationships with the Client Holdrege manufacturing site, Global Quality Management, and cross-functional teams.
• Serve as the lead engineering representative during FDA, ISO, and other third-party audits, and manage follow-up actions.
• Perform other duties as assigned to support business needs.

Job Requirements:

• Bachelor’s degree in Engineering, Quality Assurance, Mathematics, Statistics, or a related scientific field.
• Minimum of 3 years of experience in Medical Device Manufacturing, including Validation and PFMEA.
• At least 1 year of management or supervisory experience.
• Hands-on experience with quality tools such as MSA, TMV, Capability Analysis, PFMEA, Validation, 8D, and 5 Why.
• Proficient knowledge of Quality Systems and statistical/sampling plans.

Preferred Qualifications:

• Master’s degree in a related field.
• Project management experience.
• Six Sigma certification or equivalent training.
• Strong background in Risk Management.
• Expertise in Root Cause Analysis and CAPA (Corrective and Preventive Action) methodologies.

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