Senior Quality Assurance Specialist
|, Maryland - United States
$80,000.00 - $130,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
This company is a proud subsidiary of an Australian Headquartered Biotechnology/Diagnostics leader, with a landmark project to build USA manufacturing capability - fully funded via a Department of Defence strategic investment.
They are a Health Technology company that develops and manufactures rapid and accurate digital diagnostics for U.S. medical practitioners and consumers.
They achieve this by applying the working practices of our parent organisation through the integration of next-generation diagnostics, reader technology and software.
Their products are distinguished by their simplicity of use, rapid time to result and connectivity.
A world where people return to health as soon as possible.
Through the creation of simple, accurate diagnostic tools and through the linking of the results of those tools to the best treatment, we help people to get better sooner and enjoy their lives.
To create rapid, accurate diagnostic tools that link people to optimal therapy.
This senior role, reporting to the Quality Manager, will provide expert QMS guidance to ensure new product introductions and production activities are in compliance with global regulatory requirements and organisational procedures.
A particular focus of this role will be to provide support in ensuring the administration and maintenance requirements of the company’s QMS are achieved in an efficient and effective manner, and to promote and support engagement and innovation within the wider business.
DUTIES & RESPONSIBILITIES
- Act as a point of escalation for quality issues as they arise and determine further escalation when appropriate.
- Support the Non-conformance (NCR) process with regular problem-solving meetings to provide direction and standard for the stakeholder.
- Assist and lead in Corrective and Preventive Activities.
- Support implementation of planned deviations within the supporting area.
- Support design teams with document reviews and input into risk assessments.
NB This role has authorisation to release final product for sale.
- Review and authorise key manufacturing records.
- Support the Quality department in ensuring the administration and maintenance requirements of company QMS are achieved.
Participate in QMS Continuous Improvement Activities
- Identify, initiate and implement improvements to QMS processes.
- Review QMS documents for proposed changes.
- Conduct regular Internal and Supplier audits.
- Review product or design related changes.
- Review Manufacturing and Logistics process changes.
Metrics and Reporting
- Produce key performance metrics and data analysis on non-conformances
- Synthesise QMS and regulatory requirements into an appropriate and effective training content so that all employees are well-equipped to understand the process as it pertains to the regulations and company QMS.
- Ensure appropriate level of training is delivered for process changes and improvements.
- Engineering or Science Degree or equivalent
Desirable (but not essential):
- Internal or supplier audit qualifications
EXPERIENCE & SKILLS
- Demonstrated experience (> 4 years) with working in complex regulations and practical application of regulation - ISO9001, ISO13485, (FDA QSR)
- Knowledge of how to analyse processes and identify issues.
- Application of risk based methodologies to identify solutions to issues recognised.
- Excellent organisational and interpersonal skills: including the ability to competently liaise and provide feedback to internal and external customers regarding project issues.
- Being able to work independently as well as in collaboration with other teams and departments.
- Knowledge of Quality in manufacturing operations - design transfer, establishing requirements, PCP, process monitoring, high proficiency in writing procedural and technical documents.
- Passion for consistency, standards, accurate and complete documentation.
- Highly developed audit capability/experience
- Understanding of process and equipment validation
Desirable (but not essential):
- Knowledge of the application of appropriate statistical methods
- International supplier management
- Computer systems validation experience
Working knowledge of regulatory requirements for software in medical devices. (ISO62304)
University - Bachelor's Degree/3-4 Year Degree