Quality Manager

Position Title: Quality Manager Location: Holdrege, NE 68949 Schedule: Standard 8/5, 40 hours per week Interview Process Initial interview with Recruiting Manager Onsite interview (required) Position Overview We are seeking an experienced Quality Engineering Manager to lead all Quality Engineering activities at our Holdrege facility. This role will manage incoming quality issues, ensure plant quality systems are robust and compliant, and drive continuous improvement initiatives. The ideal candidate will combine technical expertise with leadership skills to build organizational capability, maintain regulatory compliance, and implement quality policies and best practices. Key Responsibilities Develop, implement, and continuously improve production and process control strategies to meet quality and plant objectives Participate in the Material Review Board and support product/process validation efforts, reviewing and approving related documentation Review and approve changes to the Device Master Record Lead strategic quality planning and oversee quality engineering projects Drive continuous improvement initiatives, including lean manufacturing, root cause analysis, control plans, Six Sigma, and statistical problem-solving Oversee vendor qualification and certification programs in collaboration with Supply Management and Supply Quality Engineering Serve as the primary engineering contact during FDA, ISO, and other third-party audits Mentor and develop quality engineering professionals to strengthen the team's capabilities Build strong working relationships with Holdrege Manufacturing, Global Quality Management, and cross-functional teams Ensure compliance with all local, state, federal, and company safety regulations Perform additional duties as needed to support business goals Basic Requirements Bachelor's degree in Engineering, Quality Assurance, Mathematics/Statistics, or a Science-related field Minimum 3 years in Medical Device Manufacturing, Validation, and PFMEA Minimum 1 year of management experience Proficiency in quality tools such as MSA, TMV, Capability Analysis, PFMEA, Validation, 8D, 5Y Strong knowledge of Quality Systems and statistical/sampling plans Preferred Qualifications Master's degree in a relevant field Project Management experience Six Sigma certification Risk Management expertise Advanced skills in Root Cause Analysis and CAPA processes

Created: 2026-03-04