Role: Design Assurance Supervisor
Location:Ballina(Hybrid working)
Department:Continence Care
Salary and benefits: Good salary, yearly bonus, pension and full family healthcare.
Company:
My client are one of the worlds leading Medical Device companies who manufacture a high volume of products for global distribution that support their ostomy care and continence care product lines using leading edge automated technologies.
Summary:
The Design Quality Assurance team is an integral part of developing and bringing to market innovative new products and technologies that make life more rewarding and dignified for people with challenging medical conditions.
The successful candidate will lead a Global Team of Design Quality Assurance Engineers and will engage with cross functional partners as part of driving the new product development process.
Responsibilities:
• Supervise Associates within the Design Assurance team
• Complete Performance Management and Development Plans with team members
• Resource planning, allocation, and monitoring on projects and initiatives
• Mentor Design Assurance team on projects and ensure completion per timelines and expectations
• Lead on Design Assurance issues raised by team members and escalate for resolution if required
• Be a core team member on SPRING or Continence Care projects as required
• Drive continuous improvement initiatives within the Design Assurance function
• Support the internal and external audit program
• Complete assigned Impact Assessments within the change control system
• Support periodic review of assigned design control procedures
• Support the development of the strategic direction for the Design Assurance function
• Manage training plans for the team
• Complete gap assessments to new standards as required
Requirements:
- 6+ years of overall experience is required
- Degree in Engineering/Science Discipline or Quality Engineering Qualification
- Relevant experience in the medical device industry or equivalent regulated industry
- Experience in Quality Systems and Design Assurance
- Working knowledge of ISO 13485 and FDA 21 CFR Regulations and BS EN ISO 1497
- Working visa for Ireland
Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR [email protected]
