Quality Manager (V&V) is required to lead a team of verification engineers and ensure regulatory compliance across the board for pharmaceutical manufacturer client in Dublin.
The Design Verification & Validation Manager is a leadership position within the Global Device Engineering (GDE) function. This role has responsibility for design verification and validation activities related to the company’s medical device products, leading a team of engineers to achieve these activities using internal and external test resources.
- Bachelor’s, Master’s or PhD Degree in Software, Electrical, Mechanical or Biomedical engineering.
- At least 10 years’ experience and a proven track record in a electromechanical medical system verification and validation role.
- Experienced with complete product or project lifecycle to submission, covering both v&v activities in compliance with industry recognized standards and medical device regulations.
- Experienced using design of experiment, data analysis and system engineering techniques.
- Be solution oriented and propose solution options.
- Knowledge and use of software tools for issue tracking and test traceability (e.g., Jira, Jama Connect).
- Strong leadership with proven track record of successful test activities in a fast-paced environment.
- Excellent written and verbal communications skills to interface with multi-disciplinary teams and management.
- Data driven.
- Process and detail oriented.
Advantageous to have:
- Certified in ISTQB, 6 Sigma or PMP preferred.
- More than 5 years of management experience in a similar role.
- Manage/Lead a team of Verification Engineers, Validation Engineers and consultants to verify and validate a diverse portfolio of medical device projects and products.
- Collaborate daily with the device engineering leadership team to ensure product inputs are traceable to objective evidence.
- Ensure process consistency and develop best practices in V&V fields.
- Identify the business needs of the company and has a thorough knowledge of the customer and clinical needs.
- Stay ahead and propose the incorporation of emerging technologies when required.
- Visualise and complete test solutions (automation, simulation and environment) and coordinate execution of test campaigns that meets Quality & Regulatory expectations and internal development processes and procedures.
- Work with the various external engineering test services, measurement systems instrumentation suppliers and HF consultancies to conduct testing on integrated products and sub modules.
- Explore multiple alternatives to solutions.
- Structure study and integrate cross-disciplinary teams (Software, Electrical, Mechanical, Systems) to arrive at an optimal solution.
- Determine V&V impacts from product updates as part of the company’s change control process.
- Work with project managers to help create project schedules.
- Resolve issues and road blocks, escalates issues in a timely fashion to R&D leadership where necessary.
- Prepare written communication.
- Convey information effectively through formal and informal documents, e.g., develops proposals, project summaries, and design documentation.
- Act as a Subject Matter Expert within MNK with respect to Verification, Validation and Reliability Engineering
- Obtain consensus, lead, influence and ensure cross-discipline participation and feedback.
- Provide mentoring in technical and organizational areas across multiple work groups; monitors the improvement of other engineer(s), e.g. delegates challenging tasks to others to help them develop; provides constructive and timely feedback.
- Participate in the evaluation of assigned staff/project team members and in the identification of development needs.
- Develop verification and validation methods to enable traceability across multiple system and subsystem levels.
- Ensure data integrity, product and design traceability, clarity and accuracy of evidence across all test deliverables.
- Provide regression analysis and impact assessments for design changes tailored to product (safety and efficacy) risks.
- Communicate with clear, accuracy with multi-disciplinary project team members, stakeholders and management.
- Communicate execution progress, test outcome and risk on a timely manner.
- Lead regular scrums with team and provide inputs to weekly project updates.
- Generate evidence for product compliance with industry recognized test standards and medical device regulations.
- Plan acquisition, development, qualification and transfer of test tools to facilitate design test automation with: Off the shelf software products, test scripts, custom electrical test harnesses and mechanical fixtures.
- Ensure adherence to industry standard accreditation and general good laboratory practices throughout internal and external verification execution activities.
- Develop innovative and best in class test techniques and methods.
Hybrid work schedule could be considered for the right candidate.
Our client offers a range of work benefits such as Health Insurance, Bonus, Paid AL, Family healthcare and pension.
Send your CV in confidence to email@example.com