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Posted: Tuesday, 14 March 2017, 10:06

Primary Location: India:New Delhi
Additional Locations: (n/a)
Job Function: Research (amp;) Development
Requisition ID:

Job Title: Quality Systems Engineer II

Location: Gurgaon, India

:a:Purpose Statement

The R(amp;)D Quality engineers will be a part of the R(amp;)D Quality organization and deployed on R(amp;)D project teams to lead the quality engineering function on individual projects. The individual will be responsible for deploying system level SOPs and developing project level Quality plans and providing quality engineering support across the PDP phase.

The individual will be responsible for all Design assurance related SOPs and documentation for the assigned projects and will provide inputs to the Quality Systems team to monitor and track all quality indicators. The individual will lead the Testing, Design and process.

The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures. Should be comfortable working in a matrix organizational structure.

Key Responsibilities/Deliverables

: Be a part of core project team and lead the quality engineering across the entire development cycle.
: Transition projects from Exploratory and Technology development (TDP) phase to product development phase (PDP) and receive ownership of all quality documentation.
: Develop and enforce Quality Plans in adherence to internal SOPs, global compliance norms and product and industry regulatory and safety requirements.

: Design Assurance, Verification (amp;) Validation
: Co:lead the development of CTQs, design input and output documents,.
: Lead the development and implementation of design verification and validation plans with project design lead.
: Lead the development and implementation of process verification and validation plans (IQ, OQ and PQ support)
: Participate and implement tools like Design of Experiments (DOEs), FMEA sessions, Risk Management and ensure compliance to CTQs and safety requirements.
: Responsible for co:leading stage gate reviews and signatory on all PDP document approvals
: Manage electronic document control and version control on all project related documents.
: Implement the global electronic document management and design assurance systems at the AMEA R(amp;)D center.
: Ensure adherence to the quality systems and design assurance SOPs and Boston Scientifics PLCP.
: Lead reliability, testing and validation testing : internal and local vendors
: Provide statistical testing and reliability plans.
: Partner with process development engineers to design transfer to manufacturing.

: Quality Systems
: Participate in Quality system audits and provide necessary support.
: Participate in continuous improvement projects for quality systems.
: Develop and support CAPA plans.
: Participate in ISO certification for the R(amp;)D center
: Regulatory
: Provide guidance on regulatory compliance requirements for ISO, BSC guidelines and external market and global guidelines i.e. MDD, FDA, QSR etc.
: Work closely with regulatory team to drive alignment of project documentation and regulatory requirements.

Develop system and provide oversight of design team activities to identify critical:to:quality design features and ensure adequate control plans for product and process designs to demonstrate product is ready to market (amp;) manufacture on an ongoing basis.

Academic Qualification and Experience

: Bachelors (or higher) degree in engineering or lifesciences with preference mechanical engineering, electronics and embedded systems, plastics and polymer engineering and biomedical engineering.
: 2 :4+ years of experience in medical device R(amp;)D Quality engineering
: in quality systems


• Location: Delhi

• Post ID: 34013953 delhi is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017