Senior Engineer - Quality Management Systems

At Blue Ocean Robotics we develop, produce and sell autonomous mobile robots (AMRs) for service applications across a range of market verticals. We aim at creating robots that make a difference in increasing quality of life and productivity for humans across the world. Our portfolio includes brands like; UVD Robots, an award winning mobile robot for disinfection; GoBe Robots, a mobile telepresence robot for communication, social inclusion and CO2 reductions and PTR Robots, a mobile robot for safe patient handling and rehabilitation.

Job summary :
The Senior Engineer in Quality Management Systems will play a pivotal role in ensuring the highest standards of quality and regulatory compliance in our medical device development processes. This position requires expertise in implementing and managing Quality Management Systems, particularly in accordance with FDA requirements for 21 CFR 820, 510(k) submission, and Denovo pathways. The successful candidate will also be a certified auditor for ISO 13485, ISO 9001, and ISO 14001.

Key Responsibilities:

• Develop, implement, and maintain a robust Quality Management System (QMS) for medical device development in compliance with ISO 13485 and FDA regulations, including 21 CFR 820.
• Lead and manage all aspects of the QMS, ensuring alignment with industry standards and best practices.
• Collaborate with cross-functional teams to establish and maintain quality objectives, metrics, and key performance indicators.
• Develop, deliver and conduct training programs on quality assurance and regulatory compliance for employees at all levels.
• Conduct awareness and training program for the cross-functional stakeholders
• Conduct internal audits to assess and improve compliance with regulatory requirements and QMS standards.
• Act as the primary point of contact during external audits for ISO 13485, ISO 9001, ISO 14001
• Provide guidance on quality-related issues, ensuring timely resolution and prevention of recurrence.
• Stay abreast of changes in regulations, standards, and industry best practices, and implement necessary updates to the QMS.
• Facilitate continuous improvement initiatives within the quality system, emphasizing efficiency and effectiveness.

Qualifications:

• Bachelor's degree in an engineering or relevant field; advanced degree preferred.
• Proven experience of at least 6-8 years in Quality Assurance and Quality Management, with a focus on medical device development.
• In-depth knowledge of ISO 13485, FDA regulations, specifically 21 CFR 820, and experience with 510(k) submissions and Denovo pathways.
• Certified Lead Auditor for ISO 13485, ISO 9001, and ISO 14001.
• Strong organizational and leadership skills, with the ability to influence and drive change.
• Excellent communication and interpersonal skills.
• Detail-oriented with a commitment to ensuring the highest standards of product quality and regulatory compliance
• We are offering a very interesting position with good opportunities to develop yourself and work in a team of highly skilled employees from many different nationalities.

What’s in it for You?

• You’ll join a growth company offering a competitive base salary.
• Company paid Holidays + Bank Holidays.
• Joining Blue Ocean Robotics’ warrant program.
• PC, phone
• A culture that values diversity, we have +25 nationalities in our company.
• Pride in working for a company that provides robots for humans.
• A long- term, advancing career path in robotics.

Who we are.
We are fast-paced, entrepreneurial, dynamic, innovative and have a flexible and very international organization. We respect each other and our differences and we take pride in being diverse and international.

We are proud to be serving humanity through our portfolio of robots.

Want to know more about Blue Ocean Robotics please visit our website: www.blue-ocean-robotics.com. You can also follow us on Linkedin, Facebook and Twitter.

Please note that we only receive applications via upload of documents on our website.

Application deadline:
As soon as possible