Quality Manager: Medical Device QMS & Team Leadership

Mt. Washington Pediatric Hospital; Dayton (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Paid vacation and holidays

Tuition assistance

Job summary

Norwood Medical in Dayton, OH is seeking a quality leader to guide manufacturing quality teams and drive compliance with ISO 13485 and FDA 21 CFR 820. The role emphasizes strategic direction, cross-functional collaboration, and mentorship across multiple projects.

The successful candidate will oversee quality functions, develop new processes, and manage employment cycles with a focus on cultivating innovation and excellence in a fast-paced medical device environment.

Qualifications

• Experience leading manufacturing quality teams.
• Strong knowledge of QA processes and ISO 13485.
• Ability to manage multiple projects concurrently.
• Excellent communication and leadership skills.

Responsibilities

• Lead and manage assigned team(s) and/or support staff by providing guidance, support, and mentoring to ensure successful execution of departmental goals.
• Oversee quality functions and projects within assigned team.
• Collaborate with leaders to define and align quality efforts with the organization’s technical and business strategies.
• Conduct research for quality activities including development of new manufacturing processes.
• Manage the full employment cycle of direct reports including career development, succession planning, employee engagement, and creating a strong culture of innovation and learning.
• Provide final decisions within assigned quality team to achieve business objectives.
• Financial analysis and review of assigned quality team impact on the organization.
• Adhere to all safety practices and support safety related activities.
• Maintain and continually improve the effectiveness of the Quality Management Systems (QMS) to compliance to ISO 13485, FDA 21 CFR 820 and other requirements.
• Ensure that customer requirements are understood and achieved including interfacing as needed.
• Prepare and present report-outs to management.

Skills

Leadership

Quality management

Team mentorship

Cross-functional collaboration

Quality inspection

GD&T

Metrology

Education

Bachelor's degree in relevant field

Job description

Norwood Medical in Dayton, OH is seeking a quality leader to guide manufacturing quality teams and drive compliance with ISO 13485 and FDA 21 CFR 820. The role emphasizes strategic direction, cross-functional collaboration, and mentorship across multiple projects.

The successful candidate will oversee quality functions, develop new processes, and manage employment cycles with a focus on cultivating innovation and excellence in a fast-paced medical device environment.