Associate Quality Engineer

Globus-Medical; Methuen (MA); On-site; USD 65,000 - 85,000; Full time

Job summary

Globus Medical is seeking a Quality Specialist to uphold the highest manufacturing quality and quality system performance, ensuring FDA and ISO 13485 compliance. You will support calibration programs, audits, and continuous improvement within a cross-functional team.

The role emphasizes problem solving, documentation control, and collaboration with Product Development, Operations, Regulatory, and Field Service to meet regulatory requirements and company standards.

Qualifications

• High School diploma or equivalent is required.
• 0-2 years’ experience in quality assurance, medical device industry preferred.
• GMP and ISO experience with focus on control of monitoring and measuring devices.

Responsibilities

• Coordinate and manage calibration programs for inspection, measuring, and test equipment.
• Maintain calibration database with equipment IDs, intervals, status, tolerances, and methods.
• Review calibration certificates for completeness and traceability.
• Assist investigations of out-of-tolerance conditions and equipment impact assessments.
• Support audits by providing calibration records, logs, and procedures.
• Contribute to nonconformance activities and continuous improvement.

Skills

Quality Assurance

Medical devices

Teamwork

Communication skills

Education

High School diploma or equivalent

Tools

Microsoft Office

Job description

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 Specialist 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 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.Essential Functions:Coordinate and manage the calibration program for inspection, measuring, and test equipment in accordance with applicable control of monitoring and measuring devices proceduresMaintain the calibration database, including equipment identification, calibration intervals, status, tolerances, and calibration methodsEnsure all equipment is calibrated on schedule using approved internal procedures or qualified external calibration suppliersReview calibration certificates for completeness, accuracy, traceability to national or international standards, and acceptance criteriaFacilitate the investigation and documentation of out-of-tolerance conditions, including equipment impact assessments and product evaluationsEnsure equipment is properly labeled with calibration status and segregation of non-calibrated or out-of-tolerance equipmentSupport audits and inspections by providing calibration records, logs, certificates, and program proceduresCoordinate equipment repairs, adjustments, re-calibration, and retirement as requiredTrend calibration data and metrics to support continuous improvementAssists with maintenance of the Quality Management System by ensuring documents are approved, issued, revised, archived, and withdrawn in compliance with applicable documentation and change control proceduresSupports training and competency requirements by creating, assigning, and managing role‑based training curricula aligned with job functions and controlled document changesContributes to nonconformance activitiesCollaborate with cross‑functional partners—Product Development, Operations, Supply Chain, Regulatory and Field Service—to clarify requirements, close gaps, and drive timely approval of documentation packagesAssist in preparation for external and internal audits by organizing documentation, gathering objective evidence, and responding to auditor requests. Support timely closure of audit observations.Provides written and oral reports to supervisor or other management personnel to keep them informed of activities and resultsAdheres 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 upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third partiesReasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.Qualifications:High School diploma or equivalent required0-2 years’ experience in quality assurance; experience in the medical device industry preferredGMP and ISO experience with a focus on control of monitoring and measuring devicesProficiency in using Microsoft Office productsMust be a team player capable of working in a deadline dictated environmentExcellent verbal and written communication skillsSelf-starterPhysical Demands:The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.Required to sit; climb or balance; and stoop, kneel, crouch or crawlRequired to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 poundsRequired to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focusOur Values:Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in 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.