Business System Analyst - QMS

USDM Life Sciences; Los Angeles (CA); Hybrid; USD 103,000 - 117,000; Full time

Job summary

USDM Life Sciences is seeking a senior Business Systems Analyst to support a regulated medical-device environment. The role focuses on translating business needs into clear requirements and improving quality processes across QA, regulatory, and IT stakeholders.

The ideal candidate brings 10+ years in analytics, strong communication, and experience with enterprise QMS/PLM platforms such as TrackWise or Teamcenter. This is a senior, fast-moving role with opportunities for impact.

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.

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.

Skills

Requirements elicitation

Process analysis

Stakeholder management

Documentation

Communication skills

Independent work

Education

Bachelor's degree in Computer Science or Information Systems

Master's Degree preferred

Tools

TrackWise

Teamcenter

QMS/PLM platforms

Job description

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

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.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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.