Dutch Ophthalmic USA

QA Engineer

• Identify and assist with process validation activities.
• Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.
• Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.
• Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).
• Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
• Inspect product including labeling and documentation for release of finished goods.
• Assist with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs
• Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
• Oversee creation and review of documentation for nonconforming products.
• Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.
• Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed
• Keep management informed of significant issues identified during production-related quality activities as well as actions being taken to improve and correct the situation.
• Assist with revisions and updates to quality procedures, standardized work instructions
• Participate in supplier management activities. Identify supplier quality issues and report to management in timely manner.
• Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).

Quality Engineer

Compliance

• Set the organizational and compliance strategy for the QA organization in the US in collaboration with the Zeiss Global Quality team.
• Ensures that the commercial and distribution activities are conducted per a QMS that ensure compliance to federal and state regulations for devices and pharmaceutical products.
• Manage and harmonize the QMS across the three US sites while respecting each site’s unique processes.
• Develop, implement and maintain quality policies and documentation.
• Acts as the local representative of DORC for regulators in North America on Quality and Compliance topics.
• Accountable for verification that DORC products that are released for distribution on the US market meet specifications and regulatory requirements such as ISO13485 or FDA regulations.
• Accountable for timely and effective executing and reporting of field corrective actions in North America.
• Executes management oversight on all locations in North America where DORC carries responsibility for FDA regulated activities.
• Reports to HQ on the effectiveness and level of compliance in DORC sites in North America through management review and other management oversight meetings.
• Drives continuous improvement of QMS governed processes aimed at increasing efficiency, effectiveness, harmonization and compliance.
• Prepare for and host external audits at DORC sites in North America and drive resolution of associate non-conformities.
• Address non-conformities and implement corrective actions.
• Educate, train and advise the organization on quality and compliance matters.
• Initiate improvement projects & initiatives.
• Timely escalation and resolution of quality or compliance concerns.
• Act as Management Representative for US.
• Lead, direct and train the quality team members.
• Oversee risk management strategies (tbc).

Quality Engineer

Quality and Compliance Manager