Senior Quality Analyst - IVD (In Vitro Diagnostics)

Qualifications Required:

• Bachelor's degree in a life science, biomedical engineering or related field.
• 3 to 5 years of quality assurance or quality control experience in IVD, medical device, or pharmaceutical/biotech settings.
• Working knowledge of ISO 13485, ISO 14971, EU IVDR and FDA medical device quality requirements.
• Hands-on experience with deviations, CAPA, change control and document control in a regulated QMS.
• Strong SOP management skills
• Strong attention to detail, clear technical writing, and the ability to manage several projects at once.

Preferred

• Experience with companion diagnostics or IVDs used in drug clinical trials.
• Familiarity with immunoassay, molecular or genetic testing methods.
• Exposure to notified body audits or FDA inspections.
• Experience with electronic QMS tools such as Veeva Vault QualityDocs or MasterControl.
• Rare disease experience, or ASQ certification (CQA or CQE).

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.