Associate Quality Engineer

Globus Medical•Methuen, MA

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. Position Summary: The Associate Quality Engineer will be responsible for achieving the highest quality level of manufacturing quality and quality system performance while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. As a contributor to the quality engineering organization, this professional will be a self-motivated and characterized as an excellent problem solver. This person will play an integral role in maintaining and improving the quality management system, product quality, and manufacturing process quality.

Requirements

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
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
Required to sit; climb or balance; and stoop, kneel, crouch or crawl
Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus

Nice To Haves

Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus

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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.