Team Lead- Design Quality

Team Lead- Design Quality

JOB SUMMARY

This position represents the quality organization as an integral team member on development projects for medical devices. The Design Quality Engineer (QE) ensures compliance to QMS and design control process and procedures and ensure maintenance of Quality Records for the design and development of the products.  They ensure adherence to customer and regulatory requirements are demonstrated and help to ensure successful transfer of the design to manufacturing.

This individual performs routine functions which require application of standard techniques, procedures, and criteria in carrying out a sequence of related engineering tasks.  Using prescribed methods, performs specific and limited portions of a broader assignment of an experienced Engineer.  Duties are assigned to provide experience and familiarization with Design Control regulations and requirements, engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

• Ensures compliance to QMS and design controls processes and procedures.
• Facilitate and support risk management activities. Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                 
• Contribute to product development and refinement of design through policies and procedures to ensure the comply with appropriate standards, regulations and industry best practice.
• Interacts with team members to ensure DFX implementation, sufficient design requirements, relevance of verification test.
• Work in a cross-functional, collaborative, team-based environment.
• Anticipate roadblocks, provide direction for navigating the quality system.
• Take an active role in Design Reviews to assess quality and compliance.
• Responsible for accurate, independent evaluation of Design History File documentation and overall compliance to the Quality System, perform independent evaluation, selection, and application in making adaptations and modifications to projects.
• Implements and understands ISO, EuMDR and regional regulatory requirements as necessary.
• Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.
• Advises team members pro-actively on technical ideas and promotes skill development of teamwork.
• Interacts with peers across projects to secure resources and commitments.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Presents effectively complex technical information/analysis and responds to questions from technical staff members and management.  
• Work direction responsibility may include leading junior engineers.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.
• Preferred experience on Medical Equipment or Disposable

MINIMUM QUALIFICATION REQUIREMENTS

Education

• Bachelors degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Experience

• Minimum 8 years of experience within a regulated industry, medical/pharma experience preferred

Skills

• Write and speak fluent English required.
• Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behaviour, and support for subordinates, junior engineers, technicians, and management.
• Problem solving skills.
• Knowledge of product development processes desired including reliability, design quality implementation, design control, statistics, test method validation
• Planning skills to prioritize and execute multiple projects required
• Detail oriented required
• Demonstrated desire to continually learn and keep up with changing technology
• Possess ability to apply fundamental techniques and latest principles of technology to develop and enhance projects
• Knowledge of ISO standards desired
• Prior experience of leading/managing Teams (preferred)

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

As per the Indian regulatory requirement

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