FGO OEM/CM Quality Engineer

As an FGO OEM/CM Quality Engineer, you'll take charge of overseeing OEM and CM quality performances, including KPIs. This means participating actively in supplier performance reviews and providing critical support to internal and external customer groups concerning compliance issues. Your role also involves ensuring regulatory compliance to GMP standards from various medical device regulatory agencies like the FDA and IMB.

To apply for the FGO OEM/CM Quality Engineer position, you should have a Bachelor’s degree in engineering or a related science field. A minimum of 2 years' experience in a manufacturing environment is essential. Additionally, knowledge of quality systems and standards such as GMP, ISO 13485, and 21 CFR Part 820 is highly preferred.

As an FGO OEM/CM Quality Engineer, your contribution to compliance during audits is paramount. You'll support both internal and external audits, ensuring that our practices align with various regulatory standards. You'll be involved in the material review board activities, assessing non-conforming products and liaising with manufacturing and quality teams, which is critical in preparing for successful audits.

In the FGO OEM/CM Quality Engineer role, you can expect a travel requirement of approximately 10%. This travel would involve liaising with suppliers as well as participating in various audits and project-related initiatives, allowing for vital hands-on interaction with the components that drive our quality standards.

As an FGO OEM/CM Quality Engineer, there are numerous opportunities for professional growth. You will engage in continuous improvement activities and contribute to cross-functional projects. The role allows you to develop and enhance your expertise in quality assurance, compliance, and supplier management within the medical device industry.

Be prepared to discuss specific examples from your past experiences where you applied GMP and ISO standards. Highlight your understanding of how these regulations impact quality in production and ensure compliance throughout the processes you managed.

Focus on detailing the specific issue you encountered, the steps you took to assess the situation, and how you collaborated with the supplier to resolve the issue while ensuring compliance with regulatory guidelines.

Illustrate your approach to project management, including how you gauge urgency and importance, collaborate with team members, and ensure that compliance requirements are met on time. Using past examples will demonstrate your ability to manage quality effectively.

Discuss specific tools like statistical software (e.g., SPC) and methodologies (like FMEA) that you have used to analyze quality performance. Explain how these helped in decision-making and driving continuous improvement.

Share your past experiences working with cross-functional teams, emphasizing collaboration, communication, and how you facilitated discussions to address quality challenges and align on objectives.

Outline your audit preparation process, including documentation review, on-site verification, and follow-ups. Highlight your approach to ensuring that audits are thorough and yield actionable insights.

This is your chance to share your insights on current challenges such as supply chain disruptions, regulatory changes, or technological advancements affecting quality assurance. Provide specifics on how you would address these challenges.

Talk about the professional resources you rely on such as industry publications, webinars, networking with peers, and participation in relevant training or certification programs to keep your knowledge current.

Discuss your commitment to quality and efficiency, detailing specific continuous improvement methodologies you've applied, such as Lean or Six Sigma, and how they produced measurable outcomes.

Provide a detailed scenario where you navigated compliance processes during a new product introduction. Highlight coordination with different teams and your determination to uphold quality standards throughout.