Quality Manager

Quality Manager Entegee - 3.7 Fitchburg, WI Job Details Contract $70 - $80 an hour 18 hours ago Qualifications Teamwork Audit engagement planning ISO standards Preventive action implementation Engineering Production deviation management Compliance audits & assessments Quality control preventive actions Corrective and preventive actions (CAPA) Change management Managing engineering teams Medical device manufacturing facility experience Mentoring Auditing experience within manufacturing industry Internal compliance assessments Regulatory/legal compliance standards in production Biomedical regulatory compliance Managing product quality assurance teams Process management Cross-functional communication Audit support Full Job Description The Quality Engineering Manager is responsible for leading quality engineering activities within a medical device manufacturing environment, ensuring compliance with regulatory requirements, quality standards, and internal procedures. This role oversees quality systems, drives continuous improvement initiatives, manages compliance activities, and provides leadership to the quality engineering team. Key Responsibilities Lead and mentor a team of Quality Engineers, fostering a culture of quality, accountability, and continuous improvement. Ensure compliance with applicable medical device regulations and quality standards, including

ISO 13485.

Manage quality system processes, including CAPA, change management, nonconformance investigations, and risk mitigation activities. Plan, coordinate, and support internal, external, and regulatory audits, ensuring timely resolution of findings. Oversee compliance management activities to maintain adherence to company, customer, and regulatory requirements. Collaborate cross-functionally with manufacturing, operations, and engineering teams to drive product and process improvements. Monitor quality metrics and implement corrective actions to improve product quality and operational performance. Required Qualifications Bachelor's degree in Engineering or a related technical discipline. Prior leadership or people management experience within a quality organization. Experience in the medical device industry with strong knowledge of

ISO 13485

requirements. Hands-on experience managing CAPA processes, change management, and quality compliance activities. Experience conducting and supporting internal, customer, and regulatory audits. Strong understanding of medical device quality systems and regulatory requirements. Excellent communication, problem-solving, and cross-functional collaboration skills. #

GRPA Pay:

$70.00 - $80.00 per hour People with a criminal record are encouraged to apply

Work Location:

In person