Job ID: MM28500524
Location: Kearney, NE
Category: Engineering
Employment Type: Permanent
Med Device Quality Engineering Manager | $130K annually + 12% bonus | Monday–Friday, Day Shift | On-site in Holdrege, NE | Direct Hire
What Matters Most
- Competitive Pay of $130,000 annually plus a 12% bonus
- Schedule: Monday–Friday, 8:00 AM – 5:00 PM
- Location: Holdrege, NE (On-site)
- Direct hire opportunity with succession planning and advancement potential
Job Description for the Med Device Quality Engineering Manager
We are seeking a dynamic Quality Engineering Manager to oversee quality processes and drive continuous improvement initiatives within our production environment. This leadership role focuses on enhancing product safety, ensuring regulatory compliance, and optimizing quality systems. The ideal candidate will lead a team of 4 quality engineers. Strong People Leadership!
Responsibilities of the Med Device Quality Engineering Manager
- Evaluate, design, implement, and improve production and process control strategies to meet quality and plant objectives
- Lead and mentor a team of four quality engineering professionals, fostering a culture of continuous improvement
- Review and approve device master record changes, validation protocols, and results
- Provide quality engineering support for product/process validation, material review boards, and strategic quality planning
- Oversee vendor qualification and certification programs in partnership with supply management
- Act as the primary engineering respondent during FDA, ISO, and other third-party audits
- Support continuous improvement initiatives, including Lean Manufacturing, Six Sigma, root cause analysis, and control plans
Qualifications and Requirements:
- Bachelor’s degree in Engineering, Quality Assurance, or a related technical field
- 3+ years of experience in the medical device industry with a focus on quality and compliance
- Proven leadership experience managing a team of technical professionals
- Strong background in quality management systems, statistical analysis, and process validation
- Proficiency with quality tools such as PFMEA, CAPA, MSA, and risk management methodologies
Preferred:
- Master’s degree or advanced certifications in Quality or Project Management
- Six Sigma certification or experience with lean manufacturing principles
- Hands-on experience with regulatory audits, including FDA and ISO compliance
Benefits and Perks:
- Competitive base salary of $130,000 plus a 12% annual bonus
- Comprehensive health benefits including medical, dental, and vision coverage
- Paid holidays, vacation, and opportunities for professional development
- Strong focus on career growth and advancement within the organization
Your New Organization
Our client is a global leader in healthcare solutions, dedicated to improving lives through innovative products and a commitment to quality. With a century-long legacy in medical advancements and a passionate team of professionals, the company fosters a supportive and inclusive work environment where your contributions truly make a difference.
Your Career Partner
The Reserves Network, a veteran-founded and family-owned company, specializes in connecting exceptional talent with rewarding opportunities. With extensive industry experience, we are dedicated to helping you achieve your professional goals and shine in your field. The Reserves Network values diversity and encourages applicants from all backgrounds to apply. As an equal-opportunity employer, we foster an environment of respect, integrity, and trust in every aspect of employment.
The base pay range for this position is $130,000 annually, plus a 12% bonus, excluding other benefits or compensation. Final compensation will depend on your skills, qualifications, experience, location, and internal pay equity. Hiring at the top of the range is uncommon to allow room for future growth.
