Nature and Scope of Job

Hiring a senior Business Systems Analyst (BSA) / Business Analyst with a strong Quality Management System (QMS) background to support business and technology initiatives across a regulated medical-device environment. The ideal candidate will bring 10+ years of experience translating business needs into clear requirements, improving quality processes, and partnering with business, quality, and IT stakeholders. Experience with TrackWise, Teamcenter, or other enterprise QMS/PLM platforms is desired. Experience with complaints management is highly desirable.

Primary Responsibilities

• Partner with Quality, Regulatory, Complaints, Operations, and IT stakeholders to understand business objectives and define practical system solutions.
• Elicit, document, and validate business, functional, and system requirements.
• Analyze current-state and future-state QMS processes and identify opportunities for improvement.
• Support requirements and process work related to complaints management, investigations, escalation, workflows, and reporting.
• Facilitate stakeholder interviews, workshops, process mapping, and fit-gap assessments.
• Translate business requirements into user stories, functional specifications, use cases, acceptance criteria, and process documentation.
• Collaborate with technical teams, vendors, and project managers throughout solution design, development, testing, and implementation.
• Support test planning, test-case development, user acceptance testing, defect triage, and business readiness activities.
• Assess impacts of system or process changes across quality, regulatory, and operational functions.
• Maintain traceability between business needs, requirements, test evidence, and delivered functionality.
• Communicate status, risks, decisions, and dependencies clearly to project and business leadership.

Required Qualifications

• 10+ years of experience as a Business Analyst, Business Systems Analyst, or comparable role.
• Demonstrated experience supporting QMS processes and systems in a regulated environment, preferably medical devices or life sciences.
• Strong requirements elicitation, process analysis, documentation, and stakeholder-management skills.
• Experience working across business and IT teams on enterprise system implementations, enhancements, or integrations.
• Ability to work independently, manage competing priorities, and operate effectively in a fast-moving environment.
• Strong written and verbal communication skills.
• Experience supporting validation, testing, change control, or other regulated-system delivery activities.

Preferred Qualifications

• Direct experience with complaints management processes or complaint-management systems.
• Experience with TrackWise, Teamcenter, or other enterprise QMS/PLM platforms.
• Experience in medical-device quality, post-market surveillance, CAPA, nonconformance, or change control processes.
• Familiarity with computer system validation, data integrity, and regulated SDLC practices.
• Experience supporting transitions, migrations, integrations, or modernization of legacy quality systems.

Education & Certifications

• Bachelor's degree in Computer Science or Information Systems or related field.
• Master's Degree preferred

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

• Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
• Operate other office productivity machinery, such as a calculator, scanner, or printer.
• Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.

Compensation

Salary/Hourly Rate Range (W2): USD 75.00 - 85.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM's compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers" href="https://usdm.com/careers"