Quality & Regulatory Leader - Medical Devices

Avalign-Technologies; Akron (OH); On-site; USD 120,000 - 180,000; Full time

Job summary

Avalign-Technologies in Akron, OH, seeks a seasoned quality leader to oversee the Quality System, ensuring product quality and regulatory compliance across the site.

The role liaises with government agencies, notified bodies, and customers, directs audits and CAPA programs, and drives continuous improvement to sustain high quality and customer satisfaction. Strong leadership and regulatory knowledge are essential.

Qualifications

• Bachelor’s degree, engineering or science preferred.
• Five (5) or more years management experience in quality assurance and/or engineering discipline preferred.
• Minimum of three (3) years’ experience in a medical device industry in quality.
• Position requires excellent leadership skills.
• Demonstrates ability to design workflows and procedures and translate concepts into clear processes.

Responsibilities

• Lead overall direction, coordination, and evaluation of quality employees; interviewing, hiring, training, assigning, directing, appraising, rewarding, disciplining.
• Act as the site Management Representative for the site quality system.
• Lead regulatory audits (including notified body, unannounced audits, and government inspections) and customer audits; follow up on audit recommendations and nonconformities.
• Manage the CAPA system including root cause investigation and verification of effectiveness.
• Manage the site Management Review process.
• Track and report site Quality Objectives and KPIs.
• Coordinate continuous improvement activities for the Quality System.
• Lead customer communication and problem solving during Manufacturing Transfer for NPIs or complaints.
• Maintain knowledge base of regulations and policies; serve as resource for Quality System.
• Drive broader quality system improvements with VP of Quality & Regulatory and site leadership.
• Ensure high level of internal and external customer service.
• Supervise quality assurance and quality control teams across sustaining and NPI initiatives.
• Mentor and train employees on quality concepts across departments.
• Manage site quality assurance efforts and regulatory compliance.
• Maintain quality system through internal and external inspection of materials and processes.
• Collaborate with cross-functional teams to meet standards and regulations.

Skills

Leadership

Quality mindset

Regulatory awareness

Communication

Problem solving

Education

Bachelor’s degree in engineering or science

Tools

Quality Management System (QMS)

Job description

Avalign-Technologies in Akron, OH, seeks a seasoned quality leader to oversee the Quality System, ensuring product quality and regulatory compliance across the site.

The role liaises with government agencies, notified bodies, and customers, directs audits and CAPA programs, and drives continuous improvement to sustain high quality and customer satisfaction. Strong leadership and regulatory knowledge are essential.