Advanced Quality Engineering

1 month ago

Bengaluru, India Fourth Frontier Full time

Position Summary:


Fourth Frontier is looking for a talented, self-driven Advanced Quality Engineering (AQE) Manager to join our expanding team. Due to continued growth our client is seeking an Advanced Quality Engineering (AQE) Manager to join their diverse engineering team where you will be working closely with product management and product design and development teams so that design control activities are completed to meet QMS requirements as well as leading RCA for complaints within the engineering investigation team.


Responsibilities:


●Establishing and maintaining appropriate frameworks for quality, design, change control, and e2e design traceability.

● Day-to-day management of the Design Control team balancing the workload across team members to deliver programme priorities.

● Reporting to the Business Design Lead on progress, issue escalation and acting as a delegate on design related topics where required.

● Leading Design Control on the Change Control Board and supporting the chair of the Design Authority on governance of changes and alignment of approvals required.

● Acting as the custodian of the programme design maintaining and communicating a single view of core baselined design artefacts across the programme and ensuring delivery workstream alignment, adherence and appropriate change management.

● Consolidating and maintaining a single view of design principles across the programme (covering both supplier and bank led design).

● Facilitating technical and business design impact assessment of changes using agreed templates and under appropriate timelines to enable awareness and agreement via agreed governance forums.

● The Design Control team plays a critical role across work streams ensuring that design activity is coordinated, aligned to scope and delivered to expected quality standards. To achieve this, the team interacts with a range of stakeholders across the programme including Policy, Design, Architecture, Commercial, RAQAC and Test to ensure that appropriate standards, traceability and design governance are embedded and maintained.

● Work alongside the project lead to ensure that design control deliverables are built into the project plan

● Manage design control aspects of product development projects with emphasis on template and design documentation development to ensure ISO 13485 and other applicable standards/requirements are met 

● Guiding the overall approach of design controls within product development projects and ensuring that the synergies between agile LSRT project and regulated product development are fully utilised.

● Innovative and creative engineer with excellent verbal and written communication skills

● Execute the tasks as defined in the project plan in order to achieve the project goals.

● Identify issues in a timely fashion that arise during project execution.

● Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.

● Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.

● Mentors, provides oversight and approval of complaints, activist and high-level expert in problem-solving and root-causing activities.

● Leads engineering investigation complaint team

● Recognized process owner, with expertise across multiple quality areas.

● Review and approval of change management activities, challenges effectiveness and drives strong review.

● Interpret KPI trends, drive continuous improvement process.

● Advocate of Human Factor practices, proficiency in the science of identification of mitigation.

● Engage in internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business.

● Aids in the development of validation strategies for existing products.

● Coach and mentor others in quality topics and activities.


Experience:

9-10 years’ experience in a design development role


Qualifications:

BA or BS (emphasis in engineering or related discipline preferred) or equivalent.


Skills:

● Strong requirements management and traceability experience combined with a project management skillset.

● Good understanding of business and technical design and how these evolve throughout and end-to-end programme lifecycle.

● Comfortable shaping solutions to ambiguous problems by drawing on own experience as a senior business analyst.

● Strong organisation and planning skills. This role will require a deep understanding of the programme plan, key milestones and delivery approach. The role is required to report against plans on a weekly basis while identifying, communicating and escalating risks.

● Ability to handle dependencies across a portfolio of workstreams/ projects. 

● Demonstrable experience in conducting impact assessments and leading design change in complex governance landscapes to strict timelines.

● Strong stakeholder management skills and ability to develop effective working relationships with a wide range of senior stakeholders quickly - including excellent interpersonal as well as both written and oral communication skills.

● Recent experience of resourcing, guiding and leading small and medium-sized teams to meet agreed objectives.

● Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.

● Previous experience working on large delivery programmes working with change to challenging timelines. 


Desirable criteria:

● Experience in working within a medical device company in a manufacturing or R&D environment

● Familiar with Software Development Environment

● Proficient in the use of requirements management tools such as JIRA as well as Google or MS Tools. 

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