QMS Auditor Bilingual (German / English)

BEPC Inc. - Business Excellence Professional Consulting; Leipzig; Remote; EUR 40.000 - 80.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Remote Supplier Quality Auditor to ensure compliance with quality standards in the medical device sector. This role offers the flexibility of freelance work, allowing you to conduct audits both onsite and remotely. You will engage with suppliers for Fortune 500 companies, focusing on quality assurance and regulatory compliance. The ideal candidate will possess strong language skills in English and German, along with a solid background in auditing principles. Join a forward-thinking company dedicated to connecting quality professionals with top opportunities in the life sciences and medical device industries.

Qualifikationen

• 3-5 years of auditing experience in the medical device industry.
• Knowledge of QMS standards and regulatory compliance.

Aufgaben

• Conduct supplier audits according to QMS standards.
• Prepare detailed supplier audit reports.
• Coordinate with suppliers for audit logistics.

Kenntnisse

Fluent in English

Fluent in German

QMS auditing principles

ISO 9001

ISO 13485

MDSAP

ISO 17025

21 CFR Parts 820 and 11

Microsoft Office proficiency

Leadership skills

Ausbildung

Bachelor's degree in technical or engineering field

Tools

EtQ

Microsoft Office

Jobbeschreibung

Remote Supplier Quality Auditor – Europe

Reports to : Supplier Auditing Account Manager / Division Director

Employment Type : Freelance (Part-time or Full-time)

Location : Remote (Must be based in Europe)

Seniority Level : Mid-Senior Level

Industry : Pharmaceutical Manufacturing / Medical Devices

Job Functions : Quality Assurance, Supplier Auditing

Position Overview

We are seeking a Remote Supplier Quality Auditor , based in Europe, to plan and conduct supplier quality system audits — both onsite and remote (desktop audits). The auditor will assess suppliers for Fortune 500 Medical Device companies located primarily in the European region, with a focus on suppliers based in Germany.

This long-term freelance role offers flexibility (part-time or full-time) and requires strong English and German language skills to effectively perform audits and communicate with supplier teams.

Key Responsibilities

• Coordinate with suppliers to schedule audits and manage pre-audit logistics, including travel arrangements when necessary.
• Conduct supplier audits (onsite or remote) according to applicable Quality Management System (QMS) standards and regulations.
• Prepare clear and detailed supplier audit reports meeting customer-specific requirements.
• Maintain updates in audit tracking systems (e.g., EtQ).
• Review supplier corrective actions and evaluate objective evidence for acceptance.
• Participate in audit-related meetings with clients and internal teams.
• Perform other duties as required by BEPC management.

Core Competencies

• Languages : Must be fluent in English and German (written and verbal).
• Thorough knowledge of QMS auditing principles and techniques.
• Experience auditing to standards and regulations including :
• ISO 9001
• ISO 13485
• MDSAP
• ISO 17025
• 21 CFR Parts 820 and 11
• Strong leadership and collaborative skills to engage with all levels of management.
• Self-directed with the ability to work independently and manage priorities.
• Strong relationship-building and professional communication abilities.
• Positive, proactive “Can-do” attitude and commitment to meeting deadlines.
• Proficient in Microsoft Office tools (Word, Excel).
• Strong multitasking and problem-solving skills.
• Excellent written and verbal communication abilities.

Education & Experience

• Required :
• Bachelor’s degree in a technical or engineering field.
• 3–5 years of auditing experience within the medical device industry or with associated suppliers.
• Preferred Certifications :
• Certified Quality Auditor (CQA) or Certified Medical Device Auditor (CMDA).
• ISO 9001 / 13485 certified lead auditor.
• This is a remote position requiring reliable home office setup.
• Standard work hours : Monday – Friday, 8 : 00 AM – 5 : 00 PM (flexibility needed to accommodate customer needs, including evenings or weekends).
• Flexible engagement as a part-time freelancer or full-time contractor depending on availability.

Travel Requirements

• Travel as needed :
• Freelance / Part-time : As required by assignments.
• Full-time : Approximately 60% travel for audits and client needs.

AAP / EEO Statement

BEPC Inc. is an equal opportunity employer. We are committed to ensuring equal employment opportunities for all applicants and employees, regardless of race, color, religion, sex, national origin, disability, military status, genetic information, or any other status protected by law. Employment decisions are based solely on qualifications, merit, and business needs.

Skills Snapshot

• Certified Quality Auditor (CQA) / Lead Auditor preferred
• Proficiency in Microsoft Office
• Expertise in QMS standards and regulatory compliance

About BEPC, Inc.

At BEPC, we believe in building long-term, mutually rewarding relationships. We are dedicated to connecting quality professionals with top opportunities across the life sciences and medical device industries. Join us in making an impact across the globe!