Quality Specialist

The Quality Specialist position is 100% REMOTE, M-F 8 am-4:30 pm CST. They are responsible for supporting the Quality Management System (QMS) with a solid focus on supplier quality, customer and supplier engagement, and controlled substances compliance within a regulated medical distribution environment.

This role serves as a key contributor to:

• Customer and supplier quality questionnaire completion
• Quality Agreement and contract review/management
• Development and maintenance of SOPs for controlled substance (Rx) processes and QMS operations

The role supports and maintains processes in alignment with ISO 13485 Quality Management System requirements, including risk-based thinking, supplier controls, and documented process governance.

The position requires a high level of regulatory knowledge, attention to detail, cross-functional collaboration, and the ability to ensure that all externally communicated quality information accurately reflects the organization’s compliance posture. Minimum Qualifications:

• Bachelor’s degree in a scientific, healthcare, or quality-related field (or equivalent experience)
• 3–5+ years of experience in:
  • Quality, compliance, or regulated distribution/warehouse environment
• Experience with:
  • Supplier quality processes
  • Controlled substances
• Working knowledge of:
  • DEA and FDA regulatory requirements
• Advanced technical writing, documentation, and audit readiness skills

Preferred Qualifications

• Experience supporting:
  • Quality Agreement development and negotiation
  • Customer and supplier audit processes
• Experience with DEA inspections
• Certification (ASQ CQE, CQA, or equivalent)
• Experience with MasterControl or similar eQMS systems
• Background in pharmaceutical, medical device, or healthcare distribution

salary: $40 - $45 per hour
shift: First
work hours: 8 AM - 5 PM
education: Bachelors

Responsibilities

1. Customer & Supplier Quality Engagement

• Lead and coordinate completion of customer and supplier quality questionnaires, supporting:
  • Supplier qualification and onboarding
  • Customer due diligence and audits
  • Supplier file maintenance
• Ensure all responses are:
  • Standardized, accurate, complete, and aligned with current QMS procedures and operational practices
  • Supported by documented evidence and approved quality statements
• Collaborate cross-functionally (Quality, Regulatory, Operations, Legal, Security, Category Management) to gather required inputs

2. Quality Agreements & Contract Review

• Review and support negotiation of:
  • Customer Quality Agreements
  • Supplier Quality Agreements
  • Controlled substance-related contracts and service agreements

3. Controlled Substances (Rx) Process Development

• Develop and maintain SOPs governing:
  • Receipt, storage, distribution, and returns of controlled substances
  • Inventory control, reconciliation, and cycle counting
  • Loss/theft reporting and escalation processes

4. QMS SOP Development & Continuous Improvement

• Author, revise, and maintain QMS procedures, including:
  • Supplier Quality processes
  • Document control and training processes

5. Regulatory Compliance & QMS Support

• Maintain working knowledge of:
  • DEA controlled substance regulations (21 CFR Part 1300–1317)
  • FDA Good Distribution Practices / 21 CFR Part 211 (as applicable)
  • DSCSA traceability requirements
  • ISO 13485 principles

Skills

• Quality Management System
• Supplier Engagement
• Quality Questionnaires
• Contract Review
• SOP Development
• ALCOA

Qualifications

• Years of experience: 3 years
• Experience level: Experienced

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

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.