Company Description:
Infostretch is a pure-play digital engineering services firm focused on helping companies accelerate their digital initiatives from strategy and planning through execution. We leverage deep technical expertise, Agile methodologies and data-driven intelligence to modernize systems of engagement and simplify human/tech interaction. We deliver custom solutions that meet customers’ technology needs wherever they are in their digital lifecycle. Backed by Goldman Sachs and Everstone Capital, Infostretch works with both large enterprises and emerging innovators -- putting digital to work to enable new products and business models, engage with customers in new ways, and create sustainable competitive differentiation.

• Tools & Technologies:

  Provide guidance and support to new product development and product improvement projects at Digital Solutions
  Provide technical support to the project teams on software, and packaging/labeling
  Ensure Design Control deliverables are completed in accordance to the Quality Systems, Project Plans and relevant business agreements
  Utilize effective and efficient Quality Engineering techniques such as risk analysis, test method development, design of experiments, statistical data analysis, measurement system analysis, and development of sampling plans throughout the product lifecycle
  Lead the development of risk management activities and documentation
  Lead the evaluation of field issues related to design via the Issue Escalation process
  Partner with engineering, operations, quality, regulatory and other relevant functional areas to ensure products are efficiently and effectively transferred, integrated into steady-state manufacturing, and continuously improve products and processes that meet all release criteria
  Provide guidance to project teams and business partners, including suppliers, external manufacturers and developers to ensure compliance with company policies and procedures as well as medical device regulations
  Provide guidance and expertise to internal and external business partners for the interpretation, implementation, and execution of QSR and ISO requirements
  Host or support audits of internal and external processes to ensure compliance to applicable procedures and requirements
  Perform other duties as assigned by management
   
  Demonstrate knowledge, understanding and application of:
  Applicable regulatory requirements and standards for area of responsibility. Ability to apply systems knowledge to offer practical solutions to minimize compliance risk while balancing business needs
  For goals and objectives, project management process, and special assignments. Lead team to implement initiatives of significant criticality and complexity and that are broad in scope (i.e. IT assignments, MD&D sector assignments)
  
  
• Other skills:

  Years of Experience: 2-5 years in Software Development or medical device or other consumer electronics devices
  Education Required: Bachelors Degree
  BS or BA in Business, applied sciences, quality or engineering related disciplines or equivalent
  CQE, CQA, CRE, Advanced degree preferred
  Experience working in AGILE development methodology.
  Experience working in a FDA Design Control or other similar regulated environment preferred but not required.
  Experience with IEC 62304, IEC 13485 or FDA Part 820 preferred.
  Strong Credo/Business values. Strong interpersonal skills with a demonstrated ability to work across multiple functions, interdependent partnering skills, communication skills, working knowledge of PC's and software, problem solving skills, team oriented, team leadership, project management skills, multi-tasking, detail and process oriented

Disclaimer:
If you feel that this is a good match for your skillsets, please submit a current word version of your resume along with a cover letter describing your skills, experience and salary expectations. We are an Equal Opportunity Employer (EOE). You can read our job applicant privacy policy here.