About this job
- Industry: Medical devices
- Area of expertise: Regulatory
- Location: Plymouth
What is required?
- Hours per week: 40
- Education level: Academic Bachelor
About this role: Director, Quality Assurance and Regulatory Affairs
This company is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEM’s (original equipment manufacturers) to enhance the lives of patients worldwide and a provider of high-end niche batteries for specialized applications in the energy, military, and environmental markets. Looking to add a Director of Quality Assurance and Regulatory Affairs to their growing team.
• You have earned, as a minimum, a bachelor’s degree in a quality engineering or related technical field. A master’s degree is preferred.• Preferably, you are an ASQ Certified Quality Manager and/or Engineer and you have completed the Six Sigma Black Belt certification program or equivalent. You have either received an advanced Degree in Regulatory Affairs or have taken and passed the Regulatory Affairs Certification (RAC)• You will have a minimum of 15 years of experience, including at least 10 years of management experience in a healthcare or other regulated manufacturing environment.• You will have specialized knowledge in the performance of this role e.g., EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820 and Good Documentation Practices along with auditing experience.
• You are recognized as a key resource for consulting on statistical concepts including Design of Experiments, Capability Studies, Validations and risk assessment.• You will have extensive knowledge and experience with product development, design verification, validation and risk management, coupled with in-depth Quality Management System knowledge and experience.
• You have knowledge in gaining and keeping product approvals and maintaining a quality system at a level applicable to high-risk devices.• You display a great ability for critical thinking and problem solving, with demonstrated capabilities transitioning from abstract to concrete concepts.
• In your tool kit of leadership skills, you are aware of the concept of Emotional Intelligence, and you are able to share examples of your strengths as a people-developer.• You enjoy a fast-paced and complex work environment in which you are comfortable and able to make timely decisions based on, at times, limited data.
• You maintain a calm demeanor that transcends the high energy, constantly changing production environment.
Requirements
• Minimum experience:• You will have a minimum of 15 years of experience, including at least 10 years of management experience in a healthcare or other regulated manufacturing environment.
• Specialized knowledge • You will have specialized knowledge in the performance of this role e.g., EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21CFR820 and Good Documentation Practices along with auditing experience.
• You are recognized as a key resource for consulting on statistical concepts including Design of Experiments, Capability Studies, Validations and risk assessment.• You will have extensive knowledge and experience with product development, design verification, validation and risk management, coupled with in-depth Quality Management System knowledge and experience.
• You have knowledge in gaining and keeping product approvals and maintaining a quality system at a level applicable to high-risk devices.
Benefits
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Join the Brunel Family
Join the Brunel Family
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
Start applying immediately
Sending an application is quick and easy. Just make sure you have the required documents ready to go.
- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
- Resume
Any questions remaining?
Your consultant, Lisa Gardiner is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB403131
Account manager
Lisa Gardiner
Brunel USA - Boston
l.gardiner@brunel.net