GARCHING, MÜNCHEN
Quality Manager - Part Time (m/w/d)
Your Mission
- QMS Development: Develop, implement, and maintain a comprehensive Quality Management System (QMS) to ensure the highest standards. This involves creating quality policies, procedures, and standards that align with industry best practices and regulatory requirements.
- Compliance and Certification: Ensure compliance with relevant international standards and regulations (e.g., ISO, CE, FCC). Take the lead in the certification process for new products, which includes working with external certification bodies, preparing documentation, and conducting necessary tests and audits.
- Continuous Improvement and Auditing: Conduct regular internal audits to monitor compliance with the QMS and identify areas for improvement. Implement corrective and preventive actions based on audit findings and feedback, and lead continuous improvement initiatives to enhance product quality and process efficiency.
- Medical Device Production Preparation: Develop and implement strategies to transition from consumer-grade products to medical-grade devices. Ensure compliance with medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820), and prepare for the additional certification and regulatory requirements needed for medical device production.
What You Will Bring
- Extensive experience in developing, implementing, and maintaining QMS, ensuring alignment with industry best practices and regulatory requirements.
- Expertise in securing compliance with international standards and leading the certification processes for new products.
- Proven ability in conducting internal audits, implementing corrective and preventive actions, and driving continuous improvement initiatives to enhance product quality and process efficiency.
- Experience in transitioning from consumer-grade to medical-grade device production, with knowledge of medical device regulations.
- Strong knowledge of quality management principles and standards.
- Familiarity with ISO, CE, FCC, and medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
- Experience with compliance and certification processes.
- Proficiency in conducting internal audits and implementing continuous improvement initiatives.
- Ability to develop and maintain quality policies, procedures, and standards.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and organizational abilities.
- Effective communication and collaboration skills.
- Ability to work independently and manage multiple projects simultaneously.
We are looking forward to get to know you!
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