Senior Quality Systems Specialist

Senior Quality Systems Specialist

• Location: Danvers, MA
• Remote work is available one day per week. Additional remote work days can be arranged in consultation with your manager for special circumstances.

Who We Are

Samsung HME America (Healthcare and Medical Equipment) is Samsung's U.S. medical imaging organization, delivering advanced diagnostic solutions across Ultrasound, Digital Radiography, and Computed Tomography. We lead nationwide sales, marketing, service, and distribution of Samsung's imaging technologies, partnering with healthcare providers to strengthen diagnostic capabilities, streamline clinical workflows, and support better patient care. Samsung HME America also serves as the global manufacturing center for Samsung's mobile Computed Tomography (mCT) business, leading the development of advanced CT systems used by healthcare providers worldwide.

Backed by Samsung Electronics' global technology leadership, our teams work closely with clinicians to translate real-world challenges into innovative imaging solutions. Our culture combines a sense of urgency, customer focus, and clinical collaboration to advance the future of medical imaging.

Role Description

Responsible for design, maintenance and continuous improvement of the Quality Management System (QMS) in a regulated medical device environment. This position operates with a high degree of autonomy, leading cross-functional quality initiatives and accountability for full lifecycle of documentation control.

Key duties and responsibilities, other duties may be assigned:

• Own, maintain and continuously improve the enterprise QMS to ensure compliance with 21 CFR Part 820 (FDA QMSR), ISO 13485, and global standards
• Lead periodic QMS gap assessments against current regulatory requirements; develop remediation plans and present findings and recommendations to senior leadership
• Create role-based training matrices and administer training records in the QMS platform to ensure all records are current and audit-ready
• Generate and distribute training compliance reports to department heads; escalate overdue training as required; onboard new employees to QMS requirements
• Serve as the administrator and process owner of the Change Control Board; schedule, facilitate, and document all CCB meetings to ensure thorough cross-functional review of proposed changes.
• Track approved changes through implementation and closure; assess downstream impact to DHR, DMR, SOPs and labeling.
• Complete the DHR review and verify completeness and regulatory compliance prior to product disposition. Maintain DMR structure ensuring all constituent documents are current, controlled, and traceable.
• Collaborate with Operations, Engineering and Regulatory Affairs to ensure DHR content aligns with current product configuration and approved change orders.
• Maintain the controlled documents; enforce numbering, revision control and periodic review compliance.
• Assist in internal and external audits, providing real time documentation support, scribing and evidence collection
• Coordinate and execute calibration reviews: calibration schedule, upcoming due dates, initiate service orders with approved calibration vendors to ensure zero-lapse compliance across the equipment inventory.
• Maintain the calibration equipment master list including equipment ID, description, location, calibration interval, last calibration date, and next due date; update records promptly following each calibration event.
• Work independently with minimal supervision and as part of team
• Keep knowledge of all Samsung products up to date
• Attend/complete all required trainings

Qualifications and Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education & Experience

• Experience in Quality related field preferred
• 5+ years of related experience
• Excellent written, oral, and documentation skills
• Working knowledge of 21 CFR Part 820 (QMSR) and ISO 13485
• Familiarity with design control requirements (21 CFR 820.30) and their interface with the QMS.
• Skills and expertise for creating and revising SOPs.

Computer & Analytical Skills

• Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
• Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environment
• Must be excellent with technology, be able to present using a laptop computer, and be able demonstrate proficiency with MS Office package, including Excel, Word, and PowerPoint

Competencies

• High attention to detail
• Understanding of terminology and ability to share and communicate effectively within the group
• Ability to organize and prioritize tasks resulting in consistent productivity
• Ability to function within and support a team environment and build strong working relationships
• Dependable and punctual
• Ability to meet accuracy and productivity goals
• Good problem solving skills, ability to evaluate situation and prioritize factors in decision making
• Self-motivated, utilize available resources for self-improvement and development
• Flexible: able to follow directives and accomplish tasks outside of normal duties

Physical Requirements

• Regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 50 pounds
• Frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear
• Interaction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full time or as necessitated by situation

Benefits

We offer a comprehensive benefit package which includes:

• Medical (Blue Cross Blue Shield): 5 PPO Plans (with up to 95% employer contribution)
• Dental (Blue Cross Blue Shield): 2 PPO Plans (with up to 80% employer contribution)
• Vision (Blue Cross Blue Shield): 100% company paid
• Short/Long Term Disability, Life & AD&D (The Standard): 100% company paid
• 401k Retirement (Fidelity): 100% company match up to 5%
• Tax Deferred Health Care Savings Programs
• Accident Insurance, Critical Illness, Hospital Indemnity, Pet, Legal, ID Theft
• Generous paid time off, tuition reimbursement, and more!

Inclusion and Diversity Statement: We are an Equal Opportunity Employer and value diversity at all levels of the organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by applicable law. We are committed to providing reasonable accommodation to individuals with disabilities throughout the application and employment process. If you require assistance or accommodation, please contact Human Resources.

ests.