Quality Engineer II

About the role

The Quality Engineer II provides Quality Engineering support for the Arden Hills manufacturing lines and New Product Introduction (NPI) activities, ensuring delivery of the highest-quality products to customers while supporting continuous improvement initiatives and quality programs. This role partners closely with Manufacturing Engineering to support production operations and collaborates with Product Development teams to develop robust, high-quality new products.

Responsibilities

• Identify and implement effective process control systems to support the development, qualification and ongoing manufacturing of products that meet or exceed internal and external requirements.
• Support a culture of continuous improvement by driving enhancements to existing process controls.
• Proactively investigate, identify and implement best-in-class Quality Engineering practices.
• Promote quality assurance, process controls and CAPA systems designed to meet or exceed internal and external requirements.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate and resolve quality issues.
• Collaborate with production teams across all shifts to develop solutions that improve outgoing product quality.
• Provide input to and implement departmental and cross-functional engineering initiatives.
• Provide project direction, coaching and mentoring to technician team members.
• Ensure the development and execution of streamlined business systems that effectively identify and resolve quality issues.
• Participate in team decision-making while demonstrating strong communication and collaborative problem-solving skills.
• Influence cross-functional project plans, guide overall project strategy, determine when to solicit stakeholder feedback and facilitate project decisions.
• Collect and analyze process defect data, including scrap, nonconforming product and customer complaints, to support product and process improvement efforts through appropriate analytical methods.
• Lead initiatives to reduce and control manufacturing process defects by identifying root causes and implementing effective corrective and preventive actions.
• Apply Six Sigma, statistical analysis and Lean methodologies to investigate issues, improve processes and enhance product quality.

Required qualifications

• Bachelor's degree in Engineering and a minimum of 2 years' experience, or a master's degree in Engineering and a minimum of 1 year's experience, or an equivalent combination of STEM education and relevant work experience.
• Strong data analysis skills using tools such as Excel and Minitab.

Preferred qualifications

• Experience in ISO 13485 standards
• Demonstrated ability to work independently with minimal supervision.
• Experience leading process improvement and corrective action initiatives.
• Demonstrated project management success.
• Experience working in a regulated industry.
• Experience supporting New Product Introduction (NPI).