Medical Device QMS Specialist

ACTalent; United States; Remote; USD 69,000 - 110,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Health Spending Account

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick)

Job summary

Actalent is seeking a QMS Specialist to support Quality Systems and batch disposition for pharmaceutical and IVD products. The specialist will provide hands-on QA oversight across the product lifecycle, ensuring products and quality processes meet FDA, ISO, and internal requirements.

This remote role involves travel to Bridgewater, NJ, and offers opportunities for growth in a specialized environment focused on orphan drugs and complex rare disease products.

Qualifications

• Strong knowledge of FDA and QMS requirements.
• 3+ years of hands-on IVD/medical device Quality Systems experience.
• Experience with batch disposition/release.
• Proficiency in performing regulatory gap assessments and driving remediation.
• Experience with electronic QMS, investigations, CAPAs, deviations, and change controls.

Responsibilities

• Own and improve Quality Management System (QMS) processes.
• Review and approve deviations, nonconformances, investigations, CAPAs, change controls, SOPs, and controlled documents.
• Perform QA review of batch records, QC results, certificates, and support batch and lot disposition decisions while managing quality-related batch holds.
• Assess root cause, product impact, compliance risk, and determine appropriate CAPA.
• Ensure compliance with FDA requirements, 21 CFR Part 820/QMSR, and ISO risk-management principles.
• Support audits, regulatory inspections, supplier quality activities, and remediation efforts.
• Collaborate cross-functionally with Manufacturing, QC, Regulatory Affairs, and Supply Chain.

Skills

FDA & QMS knowledge

IVD/Medical devices

Batch disposition

Regulatory gap assessments

Electronic QMS & CAPAs

Education

Bachelor's degree in a scientific, engineering, or technical discipline

Job description

Job Title: QMS Specialist

Job Description

This role supports Quality Systems and batch/lot disposition for pharmaceutical and In Vitro Diagnostic (IVD) products. The specialist will provide hands-on QA oversight across the product lifecycle, ensuring products and quality processes meet FDA, ISO, and internal requirements.

Responsibilities

• Own and improve Quality Management System (QMS) processes.
• Review and approve deviations, nonconformances, investigations, CAPAs, change controls, SOPs, and controlled documents.
• Perform QA review of batch records, QC results, certificates, and support batch and lot disposition decisions while managing quality-related batch holds.
• Assess root cause, product impact, compliance risk, and determine appropriate CAPA.
• Ensure compliance with FDA requirements, 21 CFR Part 820/QMSR, and ISO risk-management principles.
• Support audits, regulatory inspections, supplier quality activities, and remediation efforts.
• Collaborate cross-functionally with Manufacturing, QC, Regulatory Affairs, and Supply Chain.

Essential Skills

• Strong knowledge of FDA and QMS requirements.
• 3+ years of hands-on IVD/medical device Quality Systems experience.
• Experience with batch disposition/release.
• Proficiency in performing regulatory gap assessments and driving remediation.
• Experience with electronic QMS, investigations, CAPAs, deviations, and change controls.

Additional Skills & Qualifications

• Bachelor's degree in a scientific, engineering, or technical discipline.
• CQA or CQE certification is a plus.
• Ability to evaluate quality/compliance risks independently and make risk-based quality decisions.

Work Environment

This is a remote position with the flexibility to travel to New Jersey 10% of the time. The role offers opportunities for growth and visibility in a specialized environment focused on orphan drugs and complex rare disease products.

Job Type & Location

This is a Contract to Hire position based out of Bridgewater, NJ.

Pay and Benefits

The pay range for this position is $50.00 - $80.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract to Hire position based out of Bridgewater, NJ.

Application Deadline

This position is anticipated to close on Nov 19, 2026.

Workplace Type

This is a fully remote position.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.