Associate Quality Engineer jobs in United States
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Globus Medical · 5 days ago

Associate Quality Engineer

Globus Medical is dedicated to improving the quality of life for patients with musculoskeletal disorders. The Associate Quality Engineer will ensure compliance with quality standards and regulations while supporting manufacturing operations and driving continuous improvement initiatives.

Health CareManufacturingMedicalMedical DeviceWellness
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H1B Sponsor Likelynote

Responsibilities

Provide real-time quality support to manufacturing operations. Assist in identifying defects, performing root-cause analysis, and implementing corrections/corrective actions. Support defect reduction initiatives and process capability improvements
Lead the containment, risk‑based evaluation, disposition, and closure of Nonconforming Material records to prevent production delays and ensure consistent product quality
Facilitate MRB (Material Review Board) activities by preparing data, coordinating cross‑functional input, and ensuring timely documentation
Drive continuous improvement in nonconforming material workflows, cycle time, and data accuracy
Support timely execution of CAPAs, ensuring proper documentation, risk assessment, and effectiveness verification. Collaborate with cross‑functional teams to maintain CAPA compliance and prevent recurrence of issues
Supports the development, implementation, and improvement of production monitoring methods and systems for product inspection and testing
Performs measurement systems analysis
Conduct thorough review of documentation, including but not limited to Document Change Orders (DCOs), engineering drawings, specifications, risk management files, and Verification & Validation (V&V) protocols and reports. Ensure documents meet regulatory, procedural, and quality system requirements and reflect appropriate risk controls and traceability
Supports the validation of manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
Assess Supplier documentation, including Certificates of Conformance, First Article Inspections, supplier process validations, quality agreements, and supplier responses to SCARs. Ensure suppliers provide adequate objective evidence and that documentation aligns with material, component, and product requirements
Verify that all documentation changes are properly justified, risk‑assessed, and approved through the appropriate change control process
Collaborate with cross‑functional partners—Product Development, Operations, Supply Chain, Regulatory and Field Service—to clarify requirements, close gaps, and drive timely approval of documentation packages
Assist in preparation for external and internal audits by organizing documentation, gathering objective evidence, and responding to auditor requests. Support timely closure of audit observations
Utilizes concepts of probability and statistical quality control to guide decisions
Establishes, follows, and improves company procedures
Provides written and oral reports to supervisor or other management personnel to keep them informed of activities and results. Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Qualification

Quality AssuranceGMP ExperienceISO ExperienceStatistical AnalysisLean ManufacturingSix SigmaTeam PlayerCommunication SkillsCritical ThinkingProblem Solving

Required

Bachelor's Degree required (science or engineering preferred)
0-2 years' experience in quality assurance; experience in the medical device industry preferred
GMP and ISO experience
Strong proficiency in MS Office with knowledge of statistical analysis tools
Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus
Must be a team player capable of working in a deadline dictated environment
Excellent verbal and written communication skills
Self-starter
Advanced critical thinking and problems-solving skills

Company

Globus Medical

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Globus Medical is a musculoskeletal implant manufacturer, driving technological advancements across a suite of spinal products.

H1B Sponsorship

Globus Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (17)
2023 (13)
2022 (8)
2021 (9)
2020 (11)

Funding

Current Stage
Public Company
Total Funding
$128.52M
Key Investors
Clarus Ventures
2012-08-03IPO
2007-08-23Series E· $110M
2007-02-05Series D· $9.45M

Leadership Team

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Norbert Johnson
CTO of Imaging, Navigation & Robotics
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Harri Hallila
Managing Director, International Advanced Technologies
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Company data provided by crunchbase