QSR Auditor II

🔥 0 minutes ago

🇲🇾 Malaysia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Medline Industries, LP

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1910

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 Private Equity Round on 2021-06

Healthcare • Logistics • Manufacturing

Medline Industries, LP is a leading healthcare company that focuses on improving clinical, financial, and operational outcomes for its customers. The company offers a wide array of over 335,000 medical products and boasts extensive warehousing capabilities with more than 28 million square feet of space. With a significant global presence of 43,000 employees, Medline provides agile and scalable solutions across all points of care, achieving a 95% next-day delivery rate within the US. The company's mission is to enhance healthcare delivery by providing superior products, supply chain resilience, and clinical expertise, all while fostering strong customer relationships through tailored, problem-solving solutions.

📋 Description

• Perform QMS audits for vendors within the scope of medical devices, drug products, cosmetic products, and laboratories • Write audit reports and follow up on supplier CAPA • Lead vendor FDA projects and supervise vendors in establishing and maintaining QMS based on 21 CFR 820 or 21 CFR 210 & 211 • Support vendors during FDA audits and provide consulting guidance to improve QMS • Monitor vendors’ quality management systems through visits and regular reviews • Provide QMS support for new vendor setup projects covering drugs, cosmetics, and laboratories • Support the corporation's GSO project • Provide necessary QMS training to vendors • Handle 510(k) cases independently in communication with buyers, QA, and suppliers • Complete assigned regulatory affairs cases, including design control and process validations • Support internal audits and CAPA follow-up as needed • Complete other assigned tasks, including change control and Kaizen projects

🎯 Requirements

• Experience performing QMS audits for vendors in medical device, drug product, cosmetic product, and laboratory scopes • Knowledge of 21 CFR 820 and 21 CFR 210 & 211 • Ability to supervise vendors in establishing and maintaining QMS • Ability to support vendors during FDA audits and provide professional QMS consulting suggestions • Ability to monitor vendor QMS and identify QMS problems through regular review and visits • QMS support experience for new vendor setup projects covering drugs, cosmetics, and laboratories • Ability to provide QMS training to vendors • Ability to independently handle 510(k) cases with buyers, QA, and suppliers • Ability to complete regulatory affairs cases such as design control and process validations within timelines • Ability to support internal audits, CAPA follow-up, change control, and Kaizen projects