Product Quality Engineer

Job Overview

Stark Pharma Solutions Inc is seeking a skilled Product Quality Engineer to engage in quality engineering tasks focused on electro-mechanical medical devices incorporating both hardware and software components. This long-term contract role offers a remote working arrangement and requires expertise in failure investigations, root cause analysis, and corrective actions within regulated medical device environments.

Key Responsibilities

• Conduct investigations into product failures and perform detailed root cause analyses.
• Support activities related to CAPA (Corrective and Preventive Actions), non-conformance reports, and complaint investigations.
• Collaborate across teams including Design, Manufacturing, Software, Hardware, and Quality to effectively resolve product-related issues.
• Analyze performance data of products and suggest enhancements to improve quality.
• Ensure compliance with regulatory standards such as FDA requirements and ISO 13485 specific to medical devices.
• Contribute to risk management efforts and ongoing continuous improvement projects.

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Minimum of five years’ experience in Product Quality Engineering within the medical device sector.
• Experience working with electro-mechanical devices that incorporate both hardware and software systems.
• Proven knowledge in conducting failure investigations, CAPA processes, root cause analysis, and risk management protocols.
• Familiarity with FDA regulations and compliance with ISO 13485 certification standards.

Additional Information

The role is a contractual position lasting for the long term and is fully remote. Interested candidates with relevant experience are encouraged to submit an updated resume. Stark Pharma Solutions actively seeks professionals interested in current and future opportunities within the medical device quality engineering field.