Associate Manager, Quality Engineering

Globus Medical•Audubon, PA

10d

About The Position

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.

Requirements

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.

Nice To Haves

Knowledge of lean manufacturing, Six Sigma, or continuous improvement methodologies is a plus.

Responsibilities

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.
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.
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.