Quality Manager

Volk Optical Inc.; Mentor (OH); Presencial; USD 120.000 - 150.000; Jornada completa

Descripción de la vacante

Volk Optical Inc. is seeking a seasoned Quality leader to drive the Quality Management System and regulatory compliance across our medical device manufacturing environment.

You will lead the quality team, manage CAPA activities, and ensure robust data-driven decision making to meet ISO 13485 and FDA QSR 820 requirements. As the Management Representative, you will coordinate audits (ISO, FDA, customer) and oversee continuous improvement initiatives, collaborating with cross-functional teams to

Formación

• Bachelor’s degree in engineering; advanced degree preferred.
• 5+ years in quality engineering/quality management in regulated manufacturing.
• Solid knowledge of ISO 13485 and FDA QSR 21 CFR 820.
• Experience with CAPA investigations and root-cause analysis.
• Knowledge of design controls and risk management (FMEA).
• Experience supporting audits and regulatory inspections.
• Strong analytical, problem-solving, and data-driven decision skills.
• Ability to influence outcomes across functions.

Responsabilidades

• Lead and develop the Quality team with accountability and continuous improvement.
• Maintain and improve the QMS in compliance with ISO 13485 and FDA QSR 820.
• Serve as Management Representative for ISO and certification audits; lead audits.
• Lead internal and external audits (ISO, FDA, customer inspections).
• Analyze quality data and report metrics to leadership for visibility and accountability.

Conocimientos

Quality leadership

Regulatory compliance

CAPA investigations

Root cause analysis

FDA QSR 820

Risk management

Design controls

Audits management

Data analytics

Educación

Bachelor’s degree in Engineering

Advanced degree preferred

Descripción del empleo

Volk is the world's leading brand in ophthalmic diagnostic and surgical lenses. Our purpose is to eradicate preventable blindness through all aspects of the work we do. Volk is a highly regarded, global organization and is a subsidiary of Halma, a FTSE 100 company. To support our ongoing growth, we are looking for you!

Primary Purpose

• Lead and develop the Quality team, fostering a culture of accountability, collaboration, and continuous improvement aligned with Volk Values


• Lead, maintain, and continuously improve the QMS in compliance with ISO 13485, FDA Quality System Regulations (21 CFR


• 820), and applicable global regulations


• Serve as Management Representative for ISO and certification audits, leading all internal and external audits, including ISO, FDA, and customer audits; experience in medical manufacturing


• Analyze quality data and trends to identify improvement opportunities; develop and report quality metrics to leadership to ensure visibility and accountability

Required Qualifications

• Bachelor’s degree in Engineering (Electrical, Biomedical, Chemical, Industrial, or related field); advanced degree preferred


• 5+ years of experience in quality engineering or quality management within a regulated manufacturing environment


• Strong knowledge of ISO 13485, FDA Quality System Regulations (21 CFR


• 820), and medical device compliance requirements


• Experience with CAPA, nonconformance investigations, and root cause analysis methodologies


• Knowledge of design controls, risk management (FMEA), verification, and validation processes


• Experience supporting audits and regulatory inspections


• Strong analytical, problem-solving, and data-driven decision-making skills


• Ability to work cross-functionally and influence outcomes at multiple levels of the organization


• #volk