Are you a meticulous and driven quality professional with experience in the medical device industry? We are seeking a Manufacturing Quality Engineer to join our team and play a pivotal role in ensuring the highest standards of product quality and regulatory compliance. If you are passionate about contributing to the advancement of medical technology and have a strong background in quality engineering, we invite you to apply.
 

Position Overview:

As a Manufacturing Quality Engineer, you will be a key contributor in providing quality guidance to Operations, Manufacturing, and Supply Chain teams. Your responsibilities will revolve around ensuring the successful transfer of medical products into manufacturing while adhering to regulatory requirements and operational procedures. Additionally, you will support the maintenance of our quality systems to ensure compliance with industry regulations and standards.

Key Responsibilities:

• Review and approve quality records for the release of finished medical devices, ensuring compliance with acceptance requirements.
• Collaborate with operations to conduct process risk management activities, including hazard identification, FMEA, and risk mitigation according to ISO 14971.
• Lead and execute validation activities (IQ, OQ, PQ) for manufacturing processes of medical device products.
• Conduct root cause analysis for non-conformance issues and implement corrective and preventive actions using CAPA procedures.
• Perform external supplier audits based on ISO 13485 or ISO 9001 standards, ensuring adherence to quality agreements.
• Partner with Operations teams to facilitate the smooth transition of design changes into manufacturing.
• Initiate, review, and approve Engineering and Manufacturing Change Orders.
• Support non-conforming root cause analysis and issue resolution within operations.
• Provide data for quality metrics and participate in management review meetings.
• Serve as a Quality Subject Matter Expert (SME) in cross-functional teams.
• Conduct training on procedures and quality-related topics.
• Assist in the qualification of new suppliers and resolution of supplier-related issues.
• Develop and maintain quality systems, including SOPs, work instructions, and forms.
• Collaborate with site leadership to ensure manufacturing quality needs are communicated and prioritized.

Education & Experience:

• Proficiency in ISO 13485:2016 and 21 CFR Part 820 regulations.
• Strong team player with a hands-on approach to establishing and maintaining quality processes.
• Familiarity with CAPA, non-conforming product investigations, change control, and more.
• Proficiency with Microsoft Office Products.
• Minimum of 2 years’ experience in quality engineering within the medical device industry.
• BA/BS degree in science, engineering, or related technical field, or equivalent experience.
• Experience with internal and external audits (FDA, Notified Body, Supplier)
• Familiarity with manufacturing and product design environments preferred.
• Experience in in vitro medical diagnostics industry is a plus.
• Ability to interact with regulatory auditors preferred.