Full-Time

Sr Quality Assurance Auditor

Confirmed live in the last 24 hours

Medline

Medline

5,001-10,000 employees

Provider of medical supplies and healthcare solutions

Healthcare

Senior

Northbrook, IL, USA

Must live in the Northfield, IL/Chicago, IL vicinity to be considered.

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s degree in microbiology, chemistry, engineering or related field.
  • At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality assurance 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, test method validation and sterilization processes.
  • 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).
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, EU MDR and other applicable global regulatory requirements for manufacturers of a diverse finished product portfolio (including APIs, sterile products, medical devices, cosmetics, pharmaceuticals, biologics/HCT/P, 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.

Medline provides a wide range of medical supplies and healthcare solutions to clients such as hospitals, nursing homes, and home health agencies. Their product catalog includes items like protective gear, wound care supplies, diabetes care products, and home diagnostics. Medline operates on a business-to-business model, selling directly to healthcare providers and institutions. They generate revenue through the sale of these medical supplies and equipment, as well as offering value-added services like supply chain management and educational resources. What sets Medline apart from its competitors is its strong focus on sustainability and resilience, demonstrated by significant investments in domestic supply chain infrastructure. The company has received recognition for its consistent value and support, including the Preferred Supplier of the Year award from the University of Texas System Supply Chain Alliance.

Company Stage

Growth Equity (Venture Capital)

Total Funding

$486.4K

Headquarters

Mundelein, Illinois

Founded

1966

Simplify Jobs

Simplify's Take

What believers are saying

  • Medline's recognition with awards like the AARC's 2024 Zenith Award and the Preferred Supplier of the Year award highlights its strong reputation and reliability in the healthcare sector.
  • The new partnership with Vetter Senior Living and expansion in Chicagoland indicate Medline's growing market presence and potential for increased business opportunities.
  • Innovations like the FitRight CONNECT Wetness Sensing System demonstrate Medline's commitment to advancing healthcare technology and improving patient care.

What critics are saying

  • The competitive nature of the medical supply industry requires Medline to continuously innovate to maintain its market position.
  • Dependence on partnerships, such as those with Microsoft and Sonoma Pharmaceuticals, could pose risks if these collaborations face challenges or dissolve.

What makes Medline unique

  • Medline's partnership with Microsoft to develop AI-powered solutions for healthcare supply chains sets it apart in the medical supply industry, emphasizing innovation and technological advancement.
  • The company's commitment to sustainability and resilience through domestic supply chain investments distinguishes it from competitors who may rely more heavily on international sources.
  • Medline's extensive product catalog and value-added services like supply chain management and educational resources provide a comprehensive offering that is unmatched by many competitors.

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