"Alerted.org

Job Title: QA SpecialistJob Description

The Quality Assurance Specialist will lead the evaluation of medical devices against biological evaluation standards. This role involves reviewing real-world usage data, assessing current biocompatibility evidence, identifying compliance gaps, and developing remediation strategies to ensure regulatory readiness and patient safety.

Responsibilities

+ Validate intended device use and actual use from survey results versus device claims and risk classifications.

+ Assess alignment with biological requirements across various endpoints.

+ Identify gaps, such as missing tests, outdated evidence, or incomplete rationales.

+ Recommend remediation actions with defined priorities, owners, and timelines.

Essential Skills

+ Ability to identify gaps and prioritize based on patient safety and regulatory impact.

+ Clear reporting to cross-functional teams including Regulatory, R&D, and Manufacturing.

+ Organize timelines, testing plans, and vendor coordination.

+ Ensure compliance down to material-level changes.

Additional Skills & Qualifications

+ Bachelor’s degree in Biomedical Engineering, Materials Science, Toxicology, Chemistry, or related field.

+ Advanced degree (Master’s or Ph.D.) preferred.

+ 5+ years in the medical device industry focusing on biocompatibility, regulatory compliance, or quality assurance.

+ Understanding of specific biological evaluation standards, with hands-on experience strongly preferred.

+ Proven track record in gap analysis, risk assessment, and remediation planning for regulatory audits or submissions.

+ Familiarity with FDA, EU MDR, and other global regulatory requirements for biocompatibility.

+ Ability to interpret survey data and link real-world use to biological risk.

+ Experience with GLP testing, laboratory protocols, and worst-case material selection.

Work Environment

This position is remote, allowing for flexibility and work-life balance. The role demands a high degree of collaboration with cross-functional teams and requires an analytical approach to problem-solving.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $70.00 - $80.00/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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Dec 29, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.