Advanced Quality Engineer (Bengaluru) in Bengaluru at Stryker Corporation

Date Posted: 9/16/2019

Job Snapshot

Job Description

Location : Bengaluru , Karnatak (India)

Seeking a passionate leader of self, people & process, and organization with the following attributes:

  • Sets direction:  An innovator who defines ways to create value and deliver on Stryker’s mission and strategic imperatives.
  • Builds organizational capability: A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.
  • Inspires others:  A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.
  • Champions talent development: An individual who focuses on maximizing the ability, potential and contributions of themselves and others.   Fosters an environment where people can excel through developing, coaching and rewarding performance.
  • Delivers results:  Need to be driven who sets high goals for personal achievement and organizational success.  He/she measures success against the best internal and external benchmarks.

What You will do:

  • You will be responsible for Risk Management, Design Inputs review, Design History File Documents review, Design Output Document review, Code Review, Test log test plans, Software verification and Validation.
  • Participate in Risk Management per ISO14971 to ensure the safety and effectiveness of product.
  • Responsible to ensure provisions of software life cycle processes are followed and associated reviews are conducted.
  • Conduct design reviews during various phases of NPD.
  • Work with team to develop robust verification, validation & release strategies to ensure product compliance, safety, reliability & effectiveness.
  • Work with team to develop robust software architecture as per quality and regulatory requirements.
  • Expert-level knowledge of current industry standards for software engineering and risk management practices ideally from the domain of safety critical applications
  • Demonstrated ability to apply software and system quality management practices in efficient and effective ways while being compliant.
  • Solutions-based approach to quality engineering, wants to provide “added value" (“quality police” attitudes won’t survive in our culture).
  • Good interpersonal and communication skills.

What you will need:

  • Looking at strong experience of 3-5 years (2+ years’ experience in new product development focused on quality engineering related activities.)
  • Strong written & verbal communication skills.
  • DQA shall drive coordination with different departments (such a R&D, Testing, Regulatory, Post Market Quality) to ensure the resulting part/product/process is safe, compliant and effective
  • Experience on NPD process and various phases of new product development.
  • Knowledge of ISO 14971, IEC 62304, 60601-1 family of standards.
  • Understanding of Quality Management Systems. (ISO 13485, 21 CRF 820, ISO 9001)
  • Awareness on programming languages, embedded software & tools.
  • Ability to review Defects (Electrical & Software)
  • Ensure that software, mechanical, electronic, and material/implant engineering follow the same approaches, wherever possible, to ensure seamless cooperation between these diverse disciplines and their associated system responsibilities.
  • Provide expertise in establishing good specifications and protocols like requirements, architecture, detailed design, verification & validation planning, etc.
  • Establish world class risk methodologies for complex systems based upon existing corporate/divisional approaches.
  • Conduct and moderate all kind of Design Reviews (e.g. SRS Reviews, source code reviews, etc.).
  • Establish overall system test design in cooperation with test engineering.
  • Educate the organization in exceptional engineering processes & practices; including good documentation, formal design reviews, code inspections and the other practices mentioned above.
  • Prioritize tasks in a deadline-driven environment.
  • Candidates with medical devices will be preferred

Qualification:

  • B.Tech/BE in Computer Science or System Engineering

Work From Home: Yes

Travel Percentage: 10%

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