Quality Manager (V&V)#ES10720

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.

Requirements:

• 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.

Responsibilities: 

• 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 emer@emtechrecruitment.ie