Job Description
We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the highest level of quality in our design and development projects.
You will work closely with our design teams to provide guidance on design quality-related issues and design control best practices. Your expertise in quality management systems and risk management will be invaluable in driving a culture of compliance and continuous improvement within our organization.
Key Responsibilities:
* Ensure proprietary design & development projects are executed in compliance with relevant regulations and international standards
* Identify and support the use of improved quality practices by R&D teams during design control activities
* Facilitate the smooth integration of quality requirements into design processes
* Review and approve relevant design history file documents, product drawings, component specifications, labelling and procedures
* Support design transfer activities for commercial and launch readiness and sustainment
* Verify and validate test method validations (protocols and reports)
* Review and approve design verification and design / process validation documents (e.g. protocols & technical reports)
* Facilitate and support the completion of projects up to and including PQ
* Risk Management Activities: Author and/or review and approve Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects
* QMS Activities: Support enterprise procedures updates that impact design and development activities
* Drive the closure of change controls and protocol non-conformance reports (PNRs)
Required Skills and Qualifications
To succeed in this role, you will need:
Education: Bachelor's Degree in Chemistry, Engineering or Quality discipline
Work Experience: 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors
Preferred Knowledge, Skills and Abilities:
* Practical experience working with design teams and providing design assurance support according to international regulatory requirements
* Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820
* Experience in Project Management
* Experience in process technology, by preference with elastomers
* Risk Management experience within design and development with good working knowledge of ISO 14971
* Excellent written and verbal communication skills
* Critical reading skills and maintain a high attention to detail
Benefits
We offer a competitive compensation package, opportunities for professional growth and development, and a dynamic work environment.
Why Join Us?
We value innovation, collaboration and customer satisfaction. Our employees are our greatest asset, and we strive to create an inclusive and supportive workplace where everyone can thrive.