Process Improvement Quality Engineer

BD - Broken Bow, NE

Full-time - Mid Level

Broken Bow, NE

Miscellaneous Manufacturing

About the position

As a Process Improvement Quality Engineer at BD, you will play a crucial role in ensuring that all activities comply with government regulations such as OSHA, EPA, FDA, and ISO, as well as company policies and procedures. This includes adhering to the Quality Systems Manual for BD Broken Bow. You will develop a comprehensive understanding of customer needs, product specifications, and functional expectations, utilizing software solutions to meet and exceed these requirements. Your expertise in EDHR software management will be essential as you manage site databases and create tools that facilitate continuous improvement. In this position, you will implement corrective, preventative, and improvement initiatives through validation and control plan implementation, employing continuous improvement and six-sigma techniques. You will participate in sustaining engineering projects and provide full process characterization with effective control plans. Clear communication is key, as you will summarize investigation activities using valid statistical techniques and ensure compliance with GMP documentation. You will maintain current knowledge of federal and regulatory agency requirements regarding medical products and coordinate with component and equipment vendors as directed by quality supervision. Your role will also involve optimizing and operating various types of test equipment, ensuring their integration with applicable software. You will independently identify opportunities for improvement in safety, quality, delivery, and cost, presenting remediation projects for prioritization. Managing holistic project timelines from conception to turnkey solutions will be a significant part of your responsibilities, leveraging cross-functional resources with minimal oversight.

Responsibilities

• Ensure compliance with government regulations (OSHA, EPA, FDA, ISO) and company policies/procedures.
• Develop extensive knowledge of customer needs, product specifications, and functional expectations.
• Act as a subject matter expert in EDHR software management, configuration, and deployment.
• Manage site databases effectively.
• Create and deploy software and/or hardware tools for continuous improvement.
• Implement corrective, preventative, and improvement initiatives through validation and control plans.
• Participate in sustaining engineering projects and provide process characterization with control plans.
• Communicate investigation activities clearly using valid statistical techniques.
• Ensure GMP documentation is maintained where required.
• Maintain knowledge of federal and regulatory agency requirements regarding medical products.
• Coordinate with component and equipment vendors regarding investigation outcomes.
• Optimize and operate various types of test equipment, ensuring software integration.
• Identify opportunities in safety, quality, delivery, and cost, presenting remediation projects for prioritization.
• Manage project timelines from conception to turnkey solutions with minimal oversight.

Requirements

• Bachelor's degree in Science, Engineering, or a related discipline.
• Extensive knowledge of government regulations and quality systems in the medical technology field.
• Experience with EDHR software management and database management.
• Strong understanding of continuous improvement methodologies, including six-sigma techniques.
• Ability to communicate effectively across functions and levels within the organization.
• Proficiency in statistical analysis and GMP documentation.

Nice-to-haves

• Experience in the medical technology industry.
• Familiarity with project management tools and techniques.
• Knowledge of software development processes.

Benefits

• Comprehensive health insurance coverage.
• 401(k) retirement savings plan with company matching.
• Paid time off and holidays.
• Opportunities for professional development and career growth.
• Employee assistance programs for mental health support.