Sr Auditor QA (Sterilization)
Job Summary JOB SUMMARY: Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements across the full spectrum of Medline products including sterile products, APIs, raw materials, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements, as well as contract sterilizers and laboratories. Perform internal audits of Medline divisions and manufacturing sites. Lead complex, critical, supplier regulatory projects involving cross-functional teams. Job Description Position requires travel of up to 50% of the time for business purposes (within state, out of state and/or internationally) Although Remote, the selected individual will be required to visit the office (Chicagolandarea). This role is primarily responsible for auditing sterilization processes to ensure compliance with regulatory standards and internal quality requirements MAJOR RESPONSIBILITIES: - Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals. - As a Subject Matter Expert, provide training and consulting services to internal departments to understand and comply with Quality Management System requirements. - Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics, medical foods, and dietary supplements), as well as contract sterilizers, laboratories and raw material suppliers. - Evaluate Medline suppliers to determine approval status. Assist in development of Regulatory/Quality Management Systems for potential suppliers. - Plan, schedule and execute complex internal audits in accordance with applicable FDA regulations, ISO standards, and other global regulatory requirements. - Conduct adequate CAPA follow-up for supplier and internal audits. - Write audit reports and communicate results to upper management. - Plan and coordinate all travel for both supplier and internal audits, both domestically and internationally. - Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies. - Aid in preparation for FDA inspections and/or audits by other regulatory agencies for both Medline facilities and suppliers. - Manage and participate in quality initiatives to maintain and improve compliance, such as evaluate internal processes, suggest and implement improvements, and create and revise applicable procedures and SOPs. - Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and Medline specifications, including novel and high-risk products and services. - Assist in integration of new acquisitions into Medline’s quality system. Perform due diligence audits for potential acquisitions. - Provide mentoring, coaching, and training to junior auditors, divisional QA team members, and divisional QA Managers. Assist in managing the rotational QA program. Education - Bachelor’s degree in microbiology, chemistry, engineering or related field. Work Experience Key requirements in a nutshell: Sterilization validations, re-validation. One or a combination of radiation (gamma/e-beam), EO (Ethylene Oxide), or Steam. Test method validations (bioburden and sterility). Along with: - At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing. - Experience with FDA regulations (21 CFR 820, 21 CFR 210/211). - Experience with ISO 13485. - Experience applying knowledge of process validation, method validation and sterilization processes. Knowledge / Skills / Abilities - Detail-oriented, with excellent oral and written communication skills. - Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions. - Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives and determining when escalation of issues is necessary. - Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. - Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally). PREFERRED JOB REQUIREMENTS - Experience with USP 61/62 for Microbial Testing of Non-Steriles. - Experience applying knowledge of process validation, method validation and sterilization processes. - Experience in CAPA (Corrective and Preventive Actions) management. Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $92,000.00 - $138,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here . Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
