QSR Auditor (Hyderabad or Delhi)

Medline Industries, LP; Hyderabad; On-site; INR 600,000 - 800,000; Full time

Job summary

A leading medical equipment manufacturer in Hyderabad seeks a Mid-Senior Level Quality Auditor to ensure compliance with various regulations. The successful candidate will conduct audits of suppliers and provide guidance for improvement. A background in Pharmacy or Life Sciences along with ISO 13485 knowledge and at least 2 years of auditing experience are required. The position involves up to 50% travel for business purposes.

Qualifications

• At least 2+ years of experience on quality audit.
• Fluent both in written and verbal English.
• Strong time management skills, ability to manage multiple assignments.

Responsibilities

• Audit Medline Asia suppliers per relevant regulations.
• Prepare and publish audit reports in a timely manner.
• Conduct CAPA follow-up and evidence review for suppliers.
• Provide guidance for vendors improving quality management systems.
• Support pre-audit and follow-up with vendors.

Skills

Quality audit experience

Solid knowledge of ISO 13485

Strong communication skills

Time management skills

Education

Pharmacy / M. Pharmacy or Life Science background

B.Tech / M.Tech in relevant field

Job description

Under direct supervision, audit Medline suppliers’ quality management system per applicable regulations.

CORE JOB RESPONSIBILITIES

1. Audit Medline Asia suppliers per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc.
2. Prepare Audit reports post audit as a part of Audit Compliance & also perform pre- assessment audit support. Draft and publish audit reports in high quality and timely.
3. Conduct adequate CAPA follow-up and evidence review for supplier in a timely manner.
4. Provide supports and guidance for vendors in improving the quality management system per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc.

• Necessary instruction, guidance and training for suppliers;
• Others

1. Support pre audit and support vendors on 3rd party audit project assigned by supervisor/manager
2. Support to conduct pre audit
3. Support to follow-up with vendors to address the problems identified during the audits

6) Other assignments related to Quality Management System, supplier audit or assigned by Manager

EDUCATION

Pharmacy / M. Pharmacy, Life science background, B.Tech / M.Tech. M Pharma OR Biotech/ Bio Medical Engineering.

CERTIFICATION

BSI (or equivalent) ISO 13485: 2016 certification.

RELEVANT WORK EXPERIENCE

• At least 2+ years of experience on quality audit.
• Third-party medical device auditor, or quality system personnel in a foreign-funded enterprise medical device company, or SQE (Supplier Quality Engineer) who is responsible for supplier audit in a foreign-funded enterprise.
• Having experience in drug, cosmetic, or laboratory audits will be considered a plus.

ADDITIONAL

• Willing to travel up to 50% of the time for business purposes (domestically and internationally).
• Fluent both in written and verbal English.
• Experience processing all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions.
• Solid knowledge of ISO 13485, FDA regulations like ICH Q7, 21 CFR 210 & 211, ISO 22716, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc.
• Strong time management skills. Ability to manage multiple assignments.
• Good reporting and presentation skills
• Good communication and cooperation skills
• Familiar with general office software.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing and Pharmaceutical Manufacturing