QA & Compliance Specialist

Job Description

Job Description

QA & COMPLIANCE SPECIALIST

Confidential Client | Scottsdale, Arizona | Full-Time

ABOUT THE ROLE

A growing Scottsdale-based organization is seeking a QA & Compliance Specialist to support quality systems, regulatory compliance, and operational readiness in a highly regulated healthcare environment.

This role manages key elements of the Quality Management System (QMS) supporting donor screening, eligibility determination, processing, cryostorage, and distribution. The position helps ensure compliance with FDA regulations, state tissue bank licensure requirements, and applicable industry standards.

The ideal candidate is detail-oriented, confident working in a regulated environment, and skilled at translating complex regulatory requirements into practical operational processes.

Work Arrangement: Primarily in-office in Scottsdale, with some flexible remote hours depending on business need.

Travel: No travel expected.

KEY RESPONSIBILITIES

• Manage and continuously improve the QMS, including SOPs, work instructions, forms, training records, document control, and change management.

• Ensure complete and compliant donor eligibility documentation, including screening, testing, medical and genetic history, and eligibility determinations.

• Oversee labeling, traceability, chain-of-custody, shipping, receipt, and tracking documentation.

• Maintain compliance with FDA 21 CFR Part 1271, including donor eligibility and current Good Tissue Practice requirements.

• Maintain applicable state tissue and sperm bank licenses, registrations, renewals, and supporting documentation.

• Prepare for and support FDA inspections, state audits, and accreditation reviews.

• Manage deviations, nonconformances, complaints, investigations, root-cause analysis, and CAPA activities.

• Support adverse reaction reporting, deviation reporting, lookback procedures, and recalls when required.

• Conduct risk assessments for process changes, new offerings, and system implementations.

• Manage supplier and vendor qualification for testing laboratories, couriers, and critical materials.

• Deliver quality and compliance training and maintain required training records.

• Track and report quality metrics, including deviations, CAPA aging, audit findings, and error trends.

• Partner with Legal, Marketing, Clinical, and Operations teams to support regulatory and privacy compliance.

QUALIFICATIONS

Required:

• Bachelor’s degree in Life Sciences, Healthcare, or a related field.

• 3+ years of quality assurance and/or regulatory compliance experience in a regulated environment.

• Prior clinic or healthcare experience.

• Working knowledge of FDA 21 CFR Part 1271 and current Good Tissue Practice.

• Experience with quality management systems, SOPs, document control, deviations, and CAPA.

• Experience supporting regulatory inspections, audits, or accreditation reviews.

• Strong writing, documentation, organization, and attention-to-detail skills.

Preferred

• Experience in tissue banking, blood banking, IVF, andrology, embryology, biologics, pharmaceuticals, or medical devices.

• Experience with donor eligibility documentation.

• Familiarity with AATB standards, ASRM guidelines, and state tissue bank regulations.

• Quality certification such as ASQ CQA, CQM, RAC, or CTBS.

• Experience with electronic QMS platforms such as MasterControl, Qualio, or ZenQMS.

WHY JOIN

Join a growing organization where your quality and compliance expertise will have a direct impact on safety, regulatory readiness, and long-term growth.

EQUAL OPPORTUNITY EMPLOYER

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Our client is a growing Scottsdale-based organization entering an important stage of expansion. With a strong leadership team and an entrepreneurial culture, the company is investing in the people, systems, and infrastructure needed to support continued growth and long-term success.

This is an environment where professionals are trusted to take ownership, bring forward ideas, and influence how the business evolves. Employees work closely with senior leadership, have visibility into key decisions, and are encouraged to improve processes rather than simply maintain them.

The organization values collaboration, accountability, sound judgment, innovation, and a willingness to roll up your sleeves when needed. It is especially well suited for professionals who enjoy building, solving problems, and creating structure in a fast-moving environment.

For the right candidate, this is more than an opportunity to step into a role—it is a chance to help shape the future of a growing organization, make a visible impact, and have your expertise genuinely valued.

Company Description

Our client is a growing Scottsdale-based organization entering an important stage of expansion. With a strong leadership team and an entrepreneurial culture, the company is investing in the people, systems, and infrastructure needed to support continued growth and long-term success.\r\n\r\nThis is an environment where professionals are trusted to take ownership, bring forward ideas, and influence how the business evolves. Employees work closely with senior leadership, have visibility into key decisions, and are encouraged to improve processes rather than simply maintain them.\r\n\r\nThe organization values collaboration, accountability, sound judgment, innovation, and a willingness to roll up your sleeves when needed. It is especially well suited for professionals who enjoy building, solving problems, and creating structure in a fast-moving environment.\r\n\r\nFor the right candidate, this is more than an opportunity to step into a role—it is a chance to help shape the future of a growing organization, make a visible impact, and have your expertise genuinely valued.