Associate Manager, Quality Engineering

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. 

Key Responsibilities:
Quality Engineering & Assurance

• Ensure all Globus products and processes meet regulatory and internal quality standards.
• Review, improve, and create inspection processes, including guidance on inspection sheets and gauging.
• Conduct and lead Part Process Performance Qualifications (PPPQ) with vendors and oversee process validations.
• Perform quarterly analyses of field complaints to identify trends, recommend design changes, and mitigate risks.
• Review and analyze vendor Non-Conforming Material Reports (NCMRs) to address quality trends and issues.
• Investigate recurring product quality problems and lead corrective actions, including CAPA, FMEA, and SCAR initiation and review.
• Participate in design reviews and manufacturing meetings to evaluate designs and suggest improvements.
• Maintain Design History Files (DHF) and ensure compliance with risk management, line extensions, design reviews, and associated documentation.
• Conduct and oversee post-market surveillance activities as required.

Process Improvement & Cost Savings Initiatives

• Investigate, identify, and implement cost-saving initiatives across:
• Approval and review processes
• Standard Operating Procedures (SOPs) and Work Instructions (WIs)
• Manufacturing processes
• Optimize process efficiency by improving task allocations, production methods, and team workflows.
• Identify and resolve process bottlenecks to keep development and manufacturing on schedule.
• Lead efforts in decommissioning outdated systems and integrating new technologies, including 3D printing advancements.

Cross-Functional Collaboration

• Work closely with Product Development (PD) teams across multiple divisions (Spine, Trauma, Joints, Power Tools, INR, Bio) to support product lifecycle management, validations, risk documentation, and MDR compliance.
• Collaborate with Purchasing to address vendor-related challenges, including supply shortages (e.g., silicone, epoxy, packaging materials).
• Support Receiving Inspection in improving inspection sheet accuracy and resolving outstanding lot inspections.
• Work with Regulatory teams (U.S. and international) to ensure compliance with standards such as EU MDR and requirements for 3D-printed implants.
• Utilize sales feedback and complaint data to enhance set and system health for improved customer satisfaction.

Qualifications & Skills:

• Bachelor’s degree in Engineering, Quality, Manufacturing, or a related field.
• 5+ years of experience in quality engineering, process improvement, or manufacturing operations.
• Strong understanding of medical device manufacturing, regulatory compliance, and quality assurance principles.
• Experience with CAPA, FMEA, SCAR, risk management, validation processes, and design controls.
• Proven ability to analyze data, identify trends, and implement process improvements.
• Excellent problem-solving, communication, and cross-functional collaboration skills.
• Knowledge of lean manufacturing, Six Sigma, or continuous improvement methodologies is a plus.

Why Join Us?

• Work with a dynamic and fast-paced team dedicated to innovation and efficiency in medical device development.
• Make a meaningful impact by improving patient care and surgical outcomes.
• Be at the forefront of cutting-edge manufacturing technologies, including 3D printing and process automation.
• Enjoy a collaborative work environment where problem-solving and continuous improvement are valued.

Our Values:

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.

• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.