Quality Manager

Position Summary

The Quality Manager oversees all aspects of quality control in wire harness production, ensuring compliance with strict industry standards and regulations. Responsibilities include designing and implementing quality management systems, conducting inspections and testing, driving continuous improvement initiatives. Collaborating with cross-functional teams, The Quality Manager addresses quality issues, implements corrective actions, and maintains documentation to ensure regulatory compliance. The Quality Manager must possess expertise in the medical device sector. Along with strong communication and leadership skills to promote a culture of quality excellence and innovation.

Primary Functions and Responsibilities:

· Develop and implement Quality Control Processes: Design, implement, and maintain robust Quality Management Systems (QMS) for wire harness manufacturing operations in compliance with ISO 9001 and the development with medical industry standards such as ISO 13485, and other relevant quality standards.

· Continuous Improvement: Drive continuous improvement initiatives to enhance the quality management system, processes, and procedures, ensuring efficiency and effectiveness in the production of wire harnesses and medical devices. Identify areas for process improvement and implement measures to increase efficiency and reduce defects.

· Supplier Quality Management: Collaborate with suppliers to ensure the quality of raw materials and components used in wire harness manufacturing, including conducting supplier audits, and implementing corrective actions as necessary.

· Quality Assurance: Oversee the inspection and testing of products throughout the manufacturing process to ensure compliance with quality standards and customer requirements.

· Root cause analysis & Corrective Actions: Lead investigations into quality issues, non-conformances, and customer complaints, identifying root causes and implementing corrective and preventive actions to prevent recurrence.

· Documentation and Compliance: Maintain accurate documentation of quality control activities, including ISO certifications and any other applicable regulatory certifications, inspection reports, test results, and corrective action plans to demonstrate compliance with regulatory requirements and industry standards.

· Training and Development: Provide training and support to production staff on quality control processes, procedures, and best practices to ensure adherence to quality standards and promote a culture of quality excellence.

· Risk Management: Conduct risk assessments and develop risk mitigation strategies to identify and minimize potential risks to product quality.

· Cross-functional Collaboration: Collaborate with cross-functional teams, including engineering, First Article, Production, and sales to address quality-related issues and drive quality improvements throughout the organization.

· Leadership: Provide leadership and direction to the quality control team, fostering a culture of quality and continuous improvement.

Qualifications and Education Requirements:

· Bachelor’s degree in engineering, quality Management, or related field.

· Minimum of 3-5 years of experience in quality management within the medical industry.

· Strong understanding of quality management systems, standards, and regulations, particularly in ISO 9001, ISO 13485, IPC/WHMA 620.

· Proven track record of developing and implementing quality control processes and procedures

· Excellent communication, leadership, visionary, and problem- solving skills.

· Ability to work effectively in a fast-paced manufacturing environment and collaborate with cross-functional teams.

Working Environment

Work requires dividing physical effort between standing, sitting, and walking. The position works indoors in a climate-controlled factory environment with time spent in both an office and manufacturing plant environment. The Quality Manager role will work on cross functional teams with subject matter experts in an all-inclusive environment.

Job Type: Full-time

Pay: Up to $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Life insurance
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Quality management: 3 years (Required)

Ability to Relocate:

• Roberts, WI 54023: Relocate before starting work (Required)

Work Location: In person