Quality Engineer

Globus Medical•Limerick, PA

About The Position

The Quality Engineer supports the manufacturing of musculoskeletal devices and instruments by developing, implementing, and improving quality systems, processes, and controls in a regulated medical-device environment. The role applies engineering principles, statistical analysis, and risk-based decision-making to investigate quality issues, support process validation and manufacturing changes, improve product quality and process efficiency, and support regulatory compliance and the Quality Management System. The position works with cross-functional teams and provides technical quality support to manufacturing, operations, product development, quality control, suppliers, customers, and other stakeholders.

Requirements

Bachelor’s degree in engineering, science, or a related STEM discipline; 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.
Knowledge of statistical methods, including SPC, MSA, DOEs, Six Sigma, and process capability, and statistical software such as Minitab or equivalent.
Familiarity with manufacturing process validation principles and risk-based quality assurance.
Understanding of GMP, ISO 13485, FDA QMSR, and related requirements.
Ability to interpret engineering drawings, technical specifications, and inspection requirements.
Proficiency in Microsoft Office, particularly Excel and Word.
Strong analytical and problem-solving skills and attention to detail.
Ability to work independently and communicate and collaborate effectively across departments, sister sites, suppliers, and customers.
Strong motivation, organizational and time-management skills, and ability to manage competing priorities and adapt to changing business needs.

Nice To Haves

Experience in medical-device manufacturing or another regulated industry.
ASQ or related professional certification.
Familiarity with Power BI or equivalent tools.
Familiarity with Python, Visual Basic, or equivalent programming for data analysis.
Familiarity with testing such as bioburden, TOC, endotoxicity, and cytotoxicity, and with sterilization processes.

Responsibilities

Support investigations and resolution of product-, process-, and systems-related nonconformances or deviations.
Analyze manufacturing data, assess process performance and trends, and develop or optimize inspection methods, sampling strategies, and process controls.
Manage supplier quality for assigned areas or product lines, including incoming quality issues, SCARs, supplier qualifications and monitoring, audits, site visits, supplier agreement updates, and assessment of supplier process changes.
Own CAPA activities, including root-cause analysis, corrective-action implementation, and effectiveness verification.
Develop, execute, and maintain manufacturing process validations (IQ/OQ/PQ) and maintain MVPs.
Perform MSA studies, including TMV and Gage R&R, to develop or optimize product inspection methods.
Evaluate manufacturing process changes, equipment transfers, and new product introductions for qualification needs and QMS impact.
Participate in risk-management activities, including risk assessments, pFMEAs, and control-plan development and maintenance.
Collaborate with cross-functional teams to identify process risks, establish controls, implement risk-mitigation strategies, and reduce product, process, and QMS risks and compliance gaps.
Provide technical guidance and quality engineering support to Manufacturing Engineering, Operations, Product Development, Quality Control, and other stakeholders.
Communicate quality findings, risks, recommendations, and project updates to internal teams, management, customers, and suppliers as applicable.
Maintain accurate and timely records according to quality system requirements.
Develop and improve QMS procedures, work instructions, and control documentation.
Support internal and external audits, including preparation, responses to findings, and corrective actions.
Analyze data for systems including NCMRs, CAPAs, defects and scrap rates, complaints, supplier quality, and training.
Develop 4-blockers or presentations on key projects and quality issues for cross-functional teams and site or senior leadership.
Lead continuous improvement of products, processes, and the QMS through Kaizens, standard work, and visual management.
Comply with company policies, applicable regulations, the Company Code of Conduct, Adva-Med Code, and MedTech Code, including required compliance training.
Demonstrate professional and ethical conduct and perform other duties as assigned.