QA Specialist II (Medical Device)

Pay Rate Low: 35 | Pay Rate High: 45
Pay Rate Low: 35 | Pay Rate High: 45

Quality Assurance Specialist II


Location: downtown Houston, TX (Onsite)

Duration: 9-12+ month contract assignment

Pay Rate: $35-$45/hr (based on experience)

Industry: Life Sciences / Medical Device / Biotech


Overview


A leading life sciences organization is seeking a Quality Assurance Specialist II to support and enhance core Quality Management System (QMS) processes. This contract role will play a key part in maintaining quality compliance, driving continuous improvement initiatives, and supporting cross-functional quality programs across operations.


This individual will work closely with Quality leadership and internal stakeholders to strengthen quality systems, improve compliance readiness, and support risk mitigation across the organization.


Key Responsibilities

• Provide Quality oversight and support for manufacturing and operational activities
  
  
• Review and approve production lots to ensure compliance with specifications and procedures
  
  
• Track, trend, and analyze quality data to identify risks and improvement opportunities
  
  
• Drive continuous improvement through metrics, investigations, and process monitoring
  
  
• Support and lead Quality System processes including deviations, CAPA, and change control
  
  
• Maintain and improve Document Control processes within an electronic QMS
  
  
• Support supplier qualification and vendor quality programs
  
  
• Participate in validation review activities (equipment, systems, process changes)
  
  
• Assist with audit readiness, hosting, and remediation activities
  
  
• Generate quality metrics and communicate compliance risks to stakeholders
  
  
• Develop and deliver QMS training across the organization
  
  
• Mentor junior team members and help foster a strong culture of quality

Quality Systems Ownership Areas

• Production lot release and record review
  
  
• Deviations, nonconformances, and CAPA investigations
  
  
• Change management and controlled implementation
  
  
• Supplier qualification and quality agreements
  
  
• Validation and qualification review
  
  
• Document control and SOP lifecycle management
  
  
• Quality metrics trending and reporting
  
  
• Audit preparation and compliance tracking

Qualifications


Education:

• Bachelor's degree required (Engineering, Biology, Chemistry, Statistics, or related field preferred)
  
  OR equivalent combination of education and 6-8+ years of relevant experience

Experience & Skills

• Strong working knowledge of Quality Management Systems within regulated environments
  
  
• Experience supporting FDA and/or ISO-regulated industries
  
  
• Hands-on experience with deviations, CAPA, change control, and investigations
  
  
• Experience with document control and electronic QMS platforms (e.g., MasterControl preferred)
  
  
• Knowledge of statistical analysis tools (Minitab, R, etc.) preferred
  
  
• Strong technical writing and investigation skills
  
  
• Familiarity with biological or analytical lab environments is a plus

Regulatory Experience (Preferred)


Experience supporting one or more of the following:

• FDA (21 CFR 820, cGMP, cGTP)
  
  
• ISO 13485, ISO 9001
  
  
• ISO 15189 / ISO 17025
  
  
• Medical device, diagnostics, or life sciences manufacturing
  
  
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