Laboratory Quality Auditor

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Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field.  Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

The Quality Auditor supports compliance, audit readiness, and continuous improvement at Applied Medical by planning, executing, and reporting on internal audits, supplier audits, and external regulatory inspections. This role operates within a laboratory quality assurance environment and ensures compliance with ISO/IEC 17025:2017, FDA Good Laboratory Practice (GLP) regulations under 21 CFR Part 58, and applicable internal procedures. Candidates with a background in laboratory quality assurance, internal auditing, regulatory compliance, or GLP-regulated environments are encouraged to apply.

Key Responsibilities

• Develop and maintain the annual internal audit schedule aligned with ISO/IEC 17025 and GLP requirements.
• Conduct independent internal audits of laboratory management and technical activities, supplier audits, and support external audits and regulatory inspections including those conducted by ANAB and the FDA.
• Maintain audit records, inspection reports, and objective evidence in accordance with document and record control procedures.
• Perform GLP study phase inspections, including protocol, in-life, data, and report phases, to ensure compliance with 21 CFR Part 58.
• Verify the effectiveness of corrective actions through follow-up audits and documented effectiveness checks.
• Review and approve GLP-controlled documents including protocols, standard operating procedures (SOPs), amendments, and final reports.
• Ensure the Quality Assurance Unit (QAU) maintains independence from study conduct and laboratory operations, and report inspection findings directly to laboratory management and the Study Director as applicable.
• Analyze audit trends and systemic risks, and deliver clear, actionable audit reports to support risk-based quality oversight.
• Collaborate with laboratory management, quality teams, Study Directors, suppliers, and external regulatory or accreditation bodies during audits and inspections.

Success in This Role Looks Like

• Maintaining a complete, traceable audit program that supports ongoing accreditation readiness and regulatory inspection preparedness.
• Identifying compliance gaps and systemic risks through thorough, independent, and risk-based audit execution.
• Delivering audit reports and corrective action follow-up that drive measurable improvements in laboratory quality systems.
• Serving as a reliable quality and compliance resource to laboratory personnel on standards interpretation and regulatory requirements.
• Sustaining QAU independence while building effective working relationships across laboratory operations, management, and external bodies.

Position Requirements

This Position Requires the Following Skills and Attributes

• Bachelor's degree in biology, microbiology, chemistry, or a related field; or equivalent experience in a regulated industry environment.
• Familiarity with quality systems and the ability to interpret and assess compliance with regulatory requirements in laboratory environments.
• Ability to conduct independent, risk-based audits and inspections with a high degree of objectivity and professional judgment.
• Strong written and verbal communication skills for audit reporting and interaction with regulatory and accreditation bodies.
• High attention to detail with the ability to assess laboratory data integrity, record-keeping practices, and electronic systems.
• Proficiency with Microsoft Office Suite, SAP, and Adobe Suite.
• Ability to read, write, and speak English; comprehend work and safety instructions; and communicate effectively across teams.
• Ability to work comfortably in laboratory and controlled environments.

Preferred

The Following Skills and Attributes Are Preferred

• Knowledge of ISO/IEC 17025:2017 and FDA GLP regulations under 21 CFR Part 58.
• Previous experience in laboratory quality assurance, internal auditing, or supporting external audits, supplier audits, or GLP-regulated environments.
• Training in auditing techniques and quality management systems.

Benefits

• Competitive compensation range: $75000 - $85000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.