Quality Manager

About the role

Under the guidance of the Director of Quality, the Quality Manager will collaborate with various functional areas such as manufacturing, engineering, sales, human resources, and finance. The primary goal is to ensure that products and processes comply with ISO9001, ISO13485, FDA, and other regulatory standards.

Responsibilities

• Prioritize, schedule, and delegate work assignments while directly supervising quality technicians to ensure conformance to customer product specifications, standards, and regulatory requirements.
• Communicate with customers regarding issues, requests, and new product introductions.
• Host customer and regulatory audits.
• Manage the material review board process, part production approval process (PPAP), first article inspection, internal audit schedule, quality team's work hours, calibration schedule, quality control plans, and receiving inspection.
• Assist in measuring parts requiring first article, in-process, and final inspection using a Romer Arm, Microview, CMM, or other metrology equipment as necessary.
• Oversee the review and creation of control plans on prototype builds.
• Assist in establishing and implementing quality procedures, specifications, testing procedures, and standards for raw materials, in-process, and finished products.
• Process customer returns and facilitate closure of non-conformance cases with the customer.
• Communicate the voice of the customer plant-wide.
• Develop training curriculum and train employees in quality-related practices and system requirements.
• Analyze internal and customer return/complaint data to identify corrective and preventive actions.
• Participate in cross-functional teams to support continuous improvement projects to enhance quality and productivity.
• Coach problem-solving techniques such as 5 why, fishbone, Pareto, and 8D methods.
• Use capability studies and gage reproducibility and repeatability along with Six Sigma methods to analyze process and measurement variations.
• Manage complaints, CAPA, and non-conforming products per applicable ISO 9001 requirements.
• Manage inputs and KPI metrics for management review processes per ISO 9001 requirements.

Essential Skills

• Root cause analysis
• Quality management
• Metal fabrication
• PPAP APQP
• Quality audit
• ISO standards

Additional Skills & Qualifications

• Experience in manufacturing, preferably in a leadership role
• Experience programming and using coordinate measuring equipment
• Proficiency in using handheld gages such as calipers, micrometers, and thread gages
• Experience in problem identification, resolution, and prevention
• Preferred experience in Six Sigma, ISO, and FDA standards
• Experience with low-volume, high product mix fabrication processes such as punch press, laser cutting, progressive die stamping, forming, hardware insertion, welding, and metal fabrication

Work Environment

The role involves working closely with different departments to ensure compliance and quality standards. The position requires the use of various metrology equipment and tools. The work environment encourages continuous improvement and problem-solving to maintain high-quality standards and productivity.

Job Type & Location

This is a Permanent position based out of Milwaukee, WI.

Pay And Benefits

The pay range for this position is $90,000.00 - $100,000.00/yr. 401k, health, dental, vision

Workplace Type

This is a fully onsite position in Milwaukee, WI.