Senior Quality Engineer Medical Device Jobs in Appleton, WI

The Senior Quality Engineer drives continuous improvement initiatives, ensuring adherence to quality standards, and mitigating risks throughout the product lifecycle. This role requires a strong understanding of quality management systems, statistical analysis, and problem-solving methodologies, along with excellent communication and leadership skills.

ESSENTIAL JOB RESPONSIBILITIES

Quality System Development & Maintenance:

• Develop, implement, and maintain robust quality management systems  
• Lead the development and revision of quality procedures, work instructions, and quality plans. 
• Conduct internal and external audits to ensure compliance with quality standards and regulatory requirements. 
• Support and participate in management reviews of the quality system.

Product & Process Quality Assurance:

• Lead and participate in Design for Manufacturability (DFM), Design for Assembly (DFA), and Design for Quality (DFQ) reviews.
• Develop and implement quality control plans, inspection methods, and test procedures for new and existing products.
• Perform root cause analysis and implement corrective and preventive actions (CAPA) for product non-conformances, customer complaints, and audit findings. 
• Utilize statistical process control (SPC), capability studies, and other statistical tools to monitor and improve process performance. 
• Oversee First Article Inspection (FAI) and Production Part Approval Process (PPAP) activities. 
• Collaborate with engineering, manufacturing, supply chain, and other cross-functional teams to ensure quality at all stages.

Supplier Quality Management:

• Participate in supplier selection and qualification processes. 
• Conduct supplier audits and assessments to ensure compliance with quality requirements. 
• Monitor supplier performance and drive corrective actions for supplier quality issues. 
• Develop and implement supplier quality agreements.

Continuous Improvement & Problem Solving:

• Lead and facilitate continuous improvement initiatives using methodologies such as Lean, Six Sigma, 8D, FMEA, etc. 
• Mentor and train junior quality engineers and other team members on quality tools and methodologies. 
• Drive a culture of quality awareness and continuous improvement throughout the organization. 
• Analyze quality data and trends to identify areas for improvement and implement proactive solutions.

Risk Management:

• Identify and assess quality risks throughout the product lifecycle. 
• Develop and implement mitigation strategies to address identified risks. 
• Participate in risk management activities (e.g., FMEA, Control Plans). 

Documentation & Reporting:

• Prepare and present quality reports, metrics, and analyses to management. 
• Maintain accurate and thorough quality records. 
• Ensure proper documentation of all quality-related activities. 

All other duties as assigned.

SUPERVISORY RESPONSIBILITIES/DIRECT REPORTS

• None.

TRAVEL

• None.

WORKING CONDITIONS

• Work environment is one of a professional office environment connected to a manufacturing facility. 
• This role would require the ability to sit for extended periods of time and work on a PC. 
• There would be times where the person would need to be able to walk out on a manufacturing floor and would need to wear appropriate personal protective
• equipment as well as navigate possible uneven surfaces. 
• Lifting/carrying of up to 20 pounds occasionally, bending, squatting, twisting rarely. 
• The position is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work). 
• Very limited exposure to equipment, machinery Powered Industrial Vehicle traffic and some chemicals.

QUALIFICATIONS

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Industrial, Manufacturing) or a related technical field. Master's degree preferred. 
• 5-8 years of progressive experience in a Quality Engineering role. 
• Proficiency in quality tools and methodologies:
• Root Cause Analysis (8D, 5 Whys, Fishbone Diagram) 
• Statistical Process Control (SPC), Process Capability Studies (Cp, Cpk) 
• Failure Mode and Effects Analysis (FMEA) 
• Control Plans 
• Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP) / First Article Inspection (FAI) 
• Lean Manufacturing and Six Sigma principles (Green Belt or Black Belt certification highly desirable).
• Experience with auditing techniques and standards. 
• Excellent analytical, problem-solving, and decision-making skills. 
• Strong written and verbal communication skills, with the ability to effectively communicate complex technical information to diverse audiences. 
• Proven ability to work independently and collaboratively in a fast-paced, dynamic environment. 
• Strong leadership and mentoring abilities. 
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and statistical software (e.g., Minitab, JMP). 

VOLLRATH'S CORE VALUES

Take Ownership: Our intention is to match our actions with our words, building trust with others.  We are united in taking responsibility for the success of Vollrath as a whole.

Empower Action: Our intention is to create a workplace where every member can thrive in their growth and contributions with excitement, confidence, and psychological safety.  We support each team member with resources and tools to strengthen collaboration and performance.

Treat All People with Respect: Our intention is to recognize the diverse experiences, styles, and backgrounds of others, treating everyone with dignity.  We aim to foster an inclusive culture where all team members can be their authentic selves and feel safe in voicing their perspectives.

Life Beyond Work: Our intention is to care for the well-being of every individual we engage with, understanding them as a whole person.  We strive to keep people mentally and physically safe, sending each person home in a condition to build a fulfilling life beyond work.  We encourage balance, allowing our colleagues to pursue their passions.

Commitment to Those Who Count on Us: Our intention is to drive innovation and practical solutions through understanding the needs of our coworkers, customers, owners, and communities.  We are dedicated to proactively addressing those needs and delivering results.