Quality Assurance Specialist

About the Role

We are seeking a Quality Assurance Specialist to join a growing team within an ISO 13485-regulated In Vitro Diagnostics (IVD) manufacturing environment. This role is ideal for a quality professional who excels at documentation review, compliance oversight, and supporting the release of high-quality products that meet regulatory standards.

As a key member of the Quality team, you will provide quality oversight for manufacturing operations, ensuring batch records and supporting documentation are accurate, complete, and compliant prior to product release. You'll collaborate cross-functionally with Manufacturing, Quality Control, and Regulatory teams to maintain quality system effectiveness and drive continuous improvement.

Key Responsibilities

• Review batch records and manufacturing documentation for accuracy, completeness, and compliance prior to product release.
• Perform review of QC records, raw material inspection records, and equipment calibration documentation.
• Support lot release activities and prepare Certificates of Analysis (CoAs) as needed.
• Review and approve quality system records, including:
  • Nonconformance Reports (NCRs)
  • Corrective and Preventive Actions (CAPAs)
  • Deviations
  • Customer complaints
  • Change controls/orders
• Participate in investigations, root cause analyses, risk assessments, and effectiveness checks.
• Maintain quality records and ensure documentation complies with internal procedures and regulatory requirements.
• Support internal audits, external audits, and regulatory inspections.
• Assist with employee training activities and quality system initiatives.
• Contribute to continuous improvement and special quality projects as business needs arise.

Qualifications

Required

• Bachelor's degree in Life Sciences, Engineering, Business, or a related field.
• 3 years of Quality Assurance experience in a regulated manufacturing environment.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Experience reviewing batch records and quality documentation.
• Strong understanding of CAPA, NCR, deviation, and change control processes.
• Excellent attention to detail and documentation review skills.
• Ability to interpret regulatory requirements and quality standards.
• Strong communication skills and ability to work effectively across departments.
• Proficiency with quality systems, reporting tools, and standard computer applications.

Preferred

• Experience in the IVD, medical device, biotechnology, or life sciences industry.
• Knowledge of the In Vitro Diagnostic Regulation (IVDR).
• Experience supporting audits, investigations, and risk management activities.

Top Skills

• ISO 13485
• Batch Record Review
• Quality Assurance
• CAPA Management
• NCR Management
• GMP Compliance
• FDA Regulations
• Document Control
• Quality Systems

Why Consider This Opportunity?

• Work within a highly regulated and impactful medical device/IVD environment.
• Gain exposure to quality systems, product release activities, audits, and compliance initiatives.
• Collaborate with cross-functional teams dedicated to delivering high-quality diagnostic products.
• Opportunity to contribute to continuous improvement and quality excellence initiatives.

This is a Contract position based out of San Diego, CA.

The pay range for this position is $30.00 - $37.00/hr.

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)

This is a fully onsite position in San Diego,CA.

This position is anticipated to close on Jul 10, 2026.

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 without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by 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 actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city 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.

Salary : $30 - $37