Full-Time

Sr Quality Assurance Auditor

Posted on 10/25/2024

Medline

Medline

5,001-10,000 employees

Provider of medical supplies and healthcare solutions

Industrial & Manufacturing
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 supplies medical products and healthcare solutions to clients like hospitals and nursing homes. They offer a variety of items, including protective gear and wound care supplies, primarily through a business-to-business model. Medline stands out from competitors with its focus on sustainability and investments in domestic supply chains. The company's goal is to improve healthcare delivery by providing reliable products and services.

Company Stage

Grant

Total Funding

$486.4K

Headquarters

Mundelein, Illinois

Founded

1966

Simplify Jobs

Simplify's Take

What believers are saying

  • Medline plans a potential $5 billion IPO in 2025, indicating strong growth prospects.
  • The rise of value-based care models aligns with Medline's cost-effective supply chain solutions.
  • Increasing demand for home diagnostics boosts Medline's market in remote patient monitoring.

What critics are saying

  • Leadership transition with COO Jim Pigott retiring in 2025 may cause strategic shifts.
  • IPO market volatility could affect Medline's planned 2025 public offering success.
  • Medline's reliance on large contracts like Sutter Health poses revenue risks if renegotiated.

What makes Medline unique

  • Medline offers a comprehensive range of medical supplies and healthcare solutions.
  • The company has a strong focus on sustainability and domestic supply chain infrastructure.
  • Medline's OptiView® Transparent Dressing is recognized for innovation in wound care.

Help us improve and share your feedback! Did you find this helpful?

INACTIVE