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 team based in Cambridge, UK!
Position
As a key member of the Quality Assurance team at Inivata, the Sr. Quality Assurance Specialist – Design Control is responsible for managing and supporting Design Control efforts. The successful candidate will manage all elements of design control and documentation; risk management, development, planning, input, output, review, verification, validation, change control, specifications, SOPs, protocols, and reports. This individual will support technology and product development (assay and medical device software) with design control activities, verification and validation activities of the product life cycle and maintain a Design History File (DHF) for the device in accordance with the approved design plan, procedures and regulations. The individual will apply “systems” thinking and knowledge of systems, reliability, risk management, standards, design V&V, test method development principles, practices and implementation to support new and sustaining IVD products. They will develop and establish procedures and support the execution of design control activities. They will work creatively and collaboratively to implement fit-for-purpose processes compliant with Quality System regulations.
Key Responsibilities:
Provide Quality oversight and leadership when collaborating with functional leads to design and build Quality System processes to work with Inivata’s existing systems and product pipelines.
Design, develop, approve, and implement Design Control Quality Systems SOPs, forms, reports, protocols, and documents associated with design control and validations processes.
Work effectively and influence multiple functions (Technology and Assay Development, Operations, Product/Program Management, Regulatory, Supply Chain, Clinical, etc.) to ensure design control expectations are met.
Provide QA support for test method (assay and bioinformatics pipeline) product development from feasibility through transfer into commercialization.
Interface with Technology and Assay Development and Manufacturing to identify and resolve defects and product quality issues.
Ensure design control documentation and requirements are met.
Perform and review/approve design control and risk management activities.
Develop/oversee the Hazard Analysis and FMEAs and other risk assessment processes and documentation (as required).
Ensure Quality Risk Management Files are in alignment with 21 CFR Part 820 design control and risk management requirements of ISO 14971:2019.
Conduct risk assessments and create/revise risk management documents as required by Standard Operating Procedures, FDA, and other medical device regulations.
Lead assessment of hazard analyses, design risk assessments, use of risk assessments, system risk assessments, and process risk assessments.
Work with product development teams to assess design changes from a systems perspective, identifying risks, delivering design mitigations and evaluating the effectiveness of the risk control measures.
Oversees risk management, CAPAs, software systems and design control audits.
Lead and represent QA in multi-departmental meetings & project teams.
Represent the company as a Quality Assurance subject matter expert during internal and external regulatory inspections.
Anticipate and manage project risks, issues, and provide specific mitigation and corrective action strategies.
Present key issues related to product quality to Quality Management.
Participate in design review activities.
Perform 3rd party management activities such as review of design control deliverables, assessment of supplier changes, supplier controls (corrective actions), quality agreements, relationship development.
Monitor, track/trend KPIs and periodically provide a summary report to management including participation in Quality Management Review meetings and Management Review meetings with Inivata Senior Leadership.
Provide coaching to QA, product development key stakeholders personnel on Quality Systems requirements and process improvement methodologies.
Identify roadblocks and barriers; develop resolutions and know when to communicate them; provide clear communication to team members to meet project expectations; analyze data; evaluate results; form conclusions; recommend process improvements.
Be a self-starting problem solver who drives results through high compliance and a positive work style.
HIPAA Compliance: Position will
Agree to abide by Employment and Confidentiality Agreements and End User Policies
Commit to stay up to date on training requirements for HIPAA
Understand the importance of the proper handling and disposal of ePHI and agrees to follow HIPAA Regulations
Abide by the requirements for the proper disposal of equipment containing ePHI
Requirements
Technical Requirement:
Bachelor’s degree in a scientific discipline required.
Minimum of 5-10 years of experience in FDA/EU regulated quality management systems with direct managerial responsibility leading all aspects of Design Control and Validation for Medical Devices.
Knowledge and demonstrated experience with LDT, IVD and IVDR required.
Knowledge and demonstrated experience with USA and EU regulatory agencies. Additional international/global regulatory experience a benefit.
Knowledge and demonstrated experience with 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, GAMP5, 21 CFR Part 11, FDA Guidance’s for Industry, EU regulations, and other standards.
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 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.
Strong organizational and management skills to handle multiple tasks/projects and ability to communicate with multi-discipline project groups.
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.
Demonstrated ability to perform internal audits of design history file and software development lifecycle records.
Demonstrated ability to interpret, apply and implement worldwide regulatory standards and laws applicable to the medical device industry.
Demonstrated ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
The ability to think strategically and maintain an attention to detail.
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 leading or 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 TRANSFORM Values guide all our activities:
Team, Results, Ambitious, Nimble, Solutions, Focused, Openness, Recognize, Make a difference
Location:
Inivata Limited is based in Cambridge, UK.
No agencies please.
The closing date for applications is 18th September 2020
We look forward to reviewing your application!