Company Description
We are a leader in liquid biopsy. Every day we transform the lives of cancer patients and their families through the power of liquid biopsy. Our tests unlock essential genomic information from a simple blood test and allow clinicians to make more informed treatment decisions for their patients.
We are dynamic and innovative, focused on the development of new ground-breaking technologies in a fast-paced and international setting. Our exceptional team of talented and driven individuals work together to combine their energy and expertise in world-class research, product development and commercialization to bring new tests to the patients that need them.
If making a difference is in your DNA and you are ready to join the liquid biopsy revolution, then you could be just the person we are looking for to join our world-leading Global Operations group.
Position
Role Overview:
The Design Quality Assurance Engineer will lead a variety of activities supporting In Vitro Diagnostic (IVD) new product development and risk management and will be responsible for quality evaluation and design control within the product development process. This position will work cross-functionally to support product design and/or maintenance of product design changes and ensure that the appropriate development controls are in place, consistent with business objectives and regulatory requirements.
Requirements
Education/Qualifications:
Technical Requirement:
Bachelor’s degree in a scientific discipline or computer science field, or related field with the equivalent combination of education and experience.
Minimum of 3-5 years of experience in FDA/EU regulated quality management systems with direct managerial responsibility leading all aspects of design control and process validation for In-vitro diagnostics (IVD).
3 or more years’ experience in a direct Quality Assurance or Engineering role in a product development core team following FDA/ISO design control requirements.
Knowledge and demonstrated experience with laboratory developed tests (LDT) and IVDs required. Knowledge and demonstrated experience with 21 CFR Part 820, IVDD, IVD-R, ISO 13485, IEC 62304, ISO 14971, GAMP5, 21 CFR Part 11, FDA Guidance’s for Industry, and other standards.
Knowledge of NextGen Sequencing technology and bioinformatics.
Knowledge and demonstrated experience of regulatory requirements for software development, computer system validation and software as a medical device (SaMD).
Extensive experience and understanding with design, development, verification, validation processes, change management, and product risk management.
Thorough understanding of software quality assurance principles, practices and metrics as well as software development and testing best practices that foster high quality software required.
Skill requirement:
The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism.
Excellent interpersonal skills with the ability to collaborate closely with Assay Development and Bioinformatics staff at varying levels to drive compliance and operational excellence.
Proven ability to lead and work effectively with and through multi-functional teams to achieve results.
Ability to speak, present data, and defend approaches in front of audiences and inspectors.
Demonstrated experience in the design, implementation, and measurement of quality systems and metrics.
Initiative in innovative approaches to quality and compliance in a fast-paced and changing business environment.
Ability to continuously assess the effectiveness of the quality system’s processes and to lead improvement initiatives.
Receptive to change and be able to drive change. Note: Any formal certification in the area of cGMP, Quality management, and/or design/validation is highly desirable.
Knowledge of Microsoft Office® applications and spreadsheet programs such as Excel, Word, Power Point, and Outlook.
Experience working with electronic quality management systems and application lifecycle management systems.
Experience actively participating in FDA and/or Notified Body inspections required.
Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail are equally important.
Other information
Our Values guide all our activities:
We are BOLD with the delivery of cutting edge science.
We are PASSIONATE we love what we do, our purpose and our impact on patients is clear
We are CARING we care for our patients, our partners, customers and colleagues
Location:
Inivata Inc is located in RTP, NC
Inivata LTD is located in Cambridge, UK
No agencies please.
We look forward to reviewing your application!