Quality Manager

Volk is the world's leading brand in ophthalmic diagnostic and surgical lenses!

The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback and must have medical device experience.

Responsibilities

• Lead, initiate, coordinate, and direct the quality control system and applicable programs.

• Ensure cGMP compliance, and identify and ensure compliance with relevant domestic and international regulations, standards and guidelines. (ISO 13485, 21 CFR 820, MDD 93/42/EEC)

• Designated as the management representative for ISO and other required certifications/audits.

• Develop standardized production, quality, and customer-service standards.

• Identify potential risks before they become a problem, focusing on root cause analysis and preventive action.

• Perform internal and external quality audits and compile detailed reports of findings

• Build a strong team through coaching, mentoring, specific training and performance evaluations.

Qualifications

• Bachelor's degree or equivalent experience in Biomedical, Chemical or Industrial Engineering

• 5+ years' relevant work experience in a medical device company

• Highly organized with excellent attention to detail

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