Quality Engineer

NML Medical; Limerick (Montgomery County); On-site; USD 90,000 - 125,000; Full time

Job summary

Globus Medical is seeking a Quality Engineer to support musculoskeletal devices and instruments manufacturing. The role drives quality systems improvement, CAPA, and supplier quality in a regulated medical device environment.

You will work with cross-functional teams to resolve quality issues, validate processes, and ensure compliance with GMP, ISO 13485, and FDA QMSR. Collaboration across sites and leadership communication are essential.

Qualifications

• Bachelor’s degree in engineering, science, or related technical discipline.

Responsibilities

• Investigate product, process, and system quality issues (NCs or deviations).
• Analyze manufacturing data to improve process performance and quality.
• Own supplier quality: SCARs, supplier qualifications, and supplier audits.
• Evaluate changes to supplier processes and assess QMS impact.
• Lead CAPA activities, root cause analysis, and effectiveness verification.
• Participate in risk management activities (PFMEAs) and control plan maintenance.
• Support internal and external audits and prepare responses to findings.

Skills

Statistical methods

Minitab

Lean Manufacturing

Six Sigma

ASQ certification

GMP knowledge

ISO 13485

Drawings interpretation

Power BI

Excel

Python

Bioburden testing

TOC testing

Education

Bachelor’s degree in engineering, Science, or related technical discipline

Tools

Minitab

Power BI

Excel

Python

Job description

Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus’ world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait. 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.

Position Summary

The Quality Engineer supports musculoskeletal devices and instruments manufacturing operations through the development, implementation, and continuous improvement of quality systems, processes, and controls within a regulated medical device environment. Working collaboratively with cross‑functional teams, this role applies engineering principles, statistical analysis, and risk‑based decision‑making to resolve quality issues, support process validation and manufacturing changes, and improve product quality and process efficiency. The position also supports regulatory compliance and overall Quality Management System.

Key Responsibilities

• Manufacturing & Supplier Quality Support investigations and resolution of product, process and systems related quality issues (NCs) or deviations.
• Analyze manufacturing data to evaluate process performance, identify trends, develop and optimize inspection methods, sampling strategies, and process controls to improve product quality and manufacturing efficiency.
• Own supplier quality for respective areas or product lines – resolution of incoming quality issues, SCARs, supplier qualifications and supplier monitoring, supplier audits, supplier site visits and updates to supplier agreements.
• Evaluate changes to supplier processes and assess the impact on Globus Medical processes and products.
• Owns corrective and preventive action (CAPA) activities, including root cause analysis, corrective action implementation, and effectiveness verification.
• Process Validation & Risk Management: Develop, execute, and maintain manufacturing process validation activities (IQ/OQ/PQ); maintain MVPs. Perform MSA (TMV and Gage R&R) studies to develop or optimize product inspections methods. Evaluate manufacturing process changes, equipment transfers, and new product introductions to determine appropriate qualifications and QMS impact. Participate in risk management activities such as risk assessments, Process Failure Mode and Effects Analyses (pFMEAs), and control plan development and maintenance. Collaborate with cross‑functional teams to identify process risks, establish appropriate controls, and support the implementation of risk mitigation strategies. Reduce the overall risk and compliance gaps related to products, processes and QMS.
• Compliance, Continuous Improvement & Technical Leadership: Provide technical guidance and quality engineering support to Manufacturing Engineering, Operations, Product Development, Quality Control, and other stakeholders. Communicate quality‑related findings, risks, recommendations, and project updates to internal teams, management, customers, and suppliers, as applicable. Maintain accurate and timely records in accordance with established quality system requirements. Develop and improve quality management system procedures, work instructions, and control documentation. Support internal and external audits, including audit preparation, responses to findings, and corrective actions. Perform data analysis for various systems such as NCMRs, CAPAs, Defects & Scrap Rate, Complaints, Supplier Quality, Trainings etc. Develops 4‑blockers or presentations for key projects or quality issues when presenting to cross functional teams or site and senior leadership. Leads Continuous Improvement of the products, processes and QMS via Kaizens, developing standard work and implementation of visual management.

Qualifications

• Education and Experience: Bachelor’s degree in engineering, Science, or a related technical discipline (STEM) preferred; equivalent education and experience may be considered.
• 2–4 years of relevant experience in Quality Engineering, Manufacturing Engineering, Quality Assurance, or a related technical field preferred.
• Experience in medical device manufacturing or another regulated industry preferred.

Technical Knowledge and Skills

• Knowledge of statistical methods (SPC, MSA, DOEs, Six Sigma, Process Capabilities), statistical software (Minitab or equivalent) and Lean Manufacturing.
• ASQ or related professional certification(s) are a plus.
• Familiarity with manufacturing process validation principles and risk‑based approaches to quality assurance.
• Understanding of Good Manufacturing Practices (GMP), ISO 13485, FDA QMSR, and related requirements.
• Ability to interpret engineering drawings, technical specifications, and inspection requirements.
• Proficiency in Microsoft Office applications, particularly Excel, Word, and familiarity with tools such as Power BI or equivalent.
• Familiarity with Python, Visual Basic or equivalent programing for data analysis is a plus.
• Familiarity with testings such as Bioburden, TOC, Endotoxicity, Cytotoxicity etc. and sterilization process.

Professional Skills and Abilities

• Strong analytical and problem‑solving skills with attention to detail.
• Ability to work independently, communicate and collaborate effectively across various departments, sister sites, suppliers, and customers.
• Strong personal motivation to excel, organizational and time management skills, with the ability to manage competing priorities and adapt to changing business needs.
• Comply with company policies, applicable regulations, the Company Code of Conduct, Adva‑Med Code, and MedTech Code, including required compliance training.
• Demonstrate professionalism and ethical conduct in all business interactions and perform other duties as assigned.

Our Values

• Passionate About Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate ab 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.
• Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
• Driven: We pursue our mission with energy and passion. We are nimble, results‑oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal Employment Opportunity

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 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.