Q&R (IN) ORU 474053

You are responsible for

Driving the design validation strategy and evidence collection throughout our projects, to ensure the product release meets customer, regulatory and business needs. Regulatory and business requirements are more and more demanding, which requires validation with sound scientific evidence.

Your primary responsibilities will be:

• Responsible for the design validation strategy in an assigned R&D project i.e. Master design validation plan by coordinating with the other stakeholders and subject matter experts of R&D, Clinical, Service, Information for Use & Regulatory, Marketing functions, traceability & evidence collection that covers User requirements validation, Service requirement validation, Information For Use (IFU) requirement validation

  
  

• Responsible for budgeting & coordination of design validation resources including test systems, validation engineers and recruitment costs

  
  

• Domain expertise in algorithm and claim validation

  
  

• Stakeholder management with functions in Clinical Science, Clinical Marketing, Innovation and Research, to keep up to date with innovations in imaging technology and to ensure clinical studies fit the evidence needs of our running projects.

Additional Responsibilities:

• Ensure that quality system requirements concerning software and computer system validation are effectively established and maintained following regulations and guidance, as applicable.

  
  

• Responsible for the overall validation strategy for new and existing computer systems throughout the entire system development lifecycle.

  
  

• Develop, lead, and own the process/procedures for System Validation, Infrastructure and Tools Qualification.

  
  

• Review and approve system documentation (including System Validation Plan, User Requirements, Validation Test Protocols, Trace Matrix, Risk Assessments and Validation Summary Report) in support of validation activities.

  
  

• Work closely with cross-functional teams to document User Requirements and Functional Specifications. Perform Risk Assessment. Develop Computer System Validation Plan(s) that is appropriate for the system risk level.

  
  

• Develop Test Plans and Deliver Validation Protocols (including Installation Qualification, Operation Qualification, and Performance Qualification). A review of executed Validation Protocols and ensure supporting test documentation complies with FDA regulations.

  
  

• Develop a Validation report with a summary of test results. Review Change Control and Change Assessment to ensure the system remains validated.

  
  

• Develop training material for System Validation and execution. Defend and support quality management and quality design practices during FDA audits. Identify compliance gaps and trends and develop and execute strategies to mitigate the gaps efficiently and effectively.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

• BS degree in Engineering; or equivalent related field.

  
  

• Minimum 5 years of related experience

  
  

• Knowledge of design controls and international standards & regulations (IEC62304, ISO13485, ISO14971)

  
  

• Proven project management skills in managing multiple stakeholders and projects

  
  

• You are a self-starter, quality-conscious, excellent communicator, problem solver and team player

  
  

• Understanding of research methodologies and clinical study design according to good clinical practices

  
  

• Excellent communication and writing skills in English

ADDITIONAL QUALIFICATIONS:

Position requires:

o   5 years of experience leading validations of various types of Product design that covers software, hardware and firmware applications, including writing and reviewing/approving process documents such as SOPs/Work Instructions, computer validation documents in a Medical Device, Pharmaceutical, or Biologics environment in the areas of Quality Assurance, Compliance, Information Technology, and Manufacturing.

• Knowledge of FDA, European Union, and GxP regulatory requirements, including 21 CFR Part 11/Annex 11, ISO 13485/14791, ICH Q9, from a Governance, Risk, and Compliance perspective. (5 Years).

  
  

• SDLC methodologies, including Waterfall, V-Model, and Agile risk-based model. (5 years);

  
  

• Validation experience is a must

  
  

• Technical experience in medical device applications. (5 years);

  
  

• Regulatory and vendor audits.

  
  

• Quality risk management techniques and tools (e.g. FMEA, SRA, etc.);

  
  

• Data governance/Integrity/life cycles and management.

  
  

• Organizational, management and leadership skills.