Quality System Analyst in Gurugram at Stryker Corporation

Date Posted: 11/20/2020

Job Snapshot

Job Description

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate
  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

What you will do

Stryker’s Neurovascular team based in Fremont, CA is looking for a curious and detail- oriented Quality Systems Analyst.  Our team is highly engaged and rooted in problem solving we are looking for someone that has similar mindset.

  • You will administer the Stryker Learning Management System with a focus on quality assurance and customer service
  • You will deliver quality assurance review (submission review) for various changes in the document control system
  • You will perform ad-hoc data investigations when necessary and as part of a team to profile and analysis data to address inquiries and monitor data quality and integrity
  • You will become a subject matter expert on the documentation system and training system software
  • You will run reports from various systems (ERP, LMS, PDM, Veeva) to aid in investigating quality issues
  • You will contribute to the development of business processes to drive efficiency and accuracy in the quality business process.
  • You will assist with external audits
  • You will be responsible for processing, collecting and preparing monthly metrics such as throughput metrics for required management meetings
  • You will contribute to continuous improvement projects

What you need

  • Bachelor’s degree 
  • 0-2 years’ experience  
  • Demonstrated experience with integrating best practices for continuous quality improvements.
  • Demonstrated ability to participate on project teams with minimal coaching.
  • Demonstrated knowledge of medical device regulatory requirements highly preferred
  • Demonstrated knowledge of ERP systems, Windchill highly preferred

Qualifications/Work Experience Required

  • 0-2 years’ experience, preferably in the medical device Industry.
  • Thorough knowledge of GMP and Quality Systems required.
  • Strong organization and project management skills
  • Ability to work well in a team environment at multiple levels
  • Ability to influence others
  • Strong interpersonal relationship skills
  • Excellent computer skills.

This position is primarily responsible for the administration of various quality systems including document control and learning management systems.

Essential Duties & Responsibilities

(detailed description)

  • Maintain accurate "change control" within the defined quality system, and archiving of obsolete materials.
  • Administer Stryker Learning Management System to support business needs, including, but not limited to, training item creation, qualifications, structure creation and maintenance, and custom reporting
  • Be the Subject Matter expert for the Stryker NV PLM and SLMS system.
  • Support the structural integrity of the implemented Quality System.
  • Effective interface & communication with functional disciplines to ensure efficient and constructive interdepartmental interactions for Documentation and change control aspects.
  • Provide training to cross functional groups on PLM and regulatory requirements related to Documentation control.
  • Periodic/requested participation in product development team settings for coordination of necessary documentation activities.
  • Offer to support to project teams and identify new business requirements and translate these into IT requests
  • Identify and lead process improvement projects
  • Support & comply with GMP/QSR, ISO 13485 & CE-mark requirements.
  • Coordinate the dissemination of controlled documents.
  • Develop & maintain quality indices for trending/management reviews.
  • Schedule & supervise Document Control maintenance activities, as necessary.
  • Maintain an organized, clean, safe & health conscious work environment.
  • Assist with company regulatory audit activities, as deemed necessary.

Work From Home: Not available

Travel Percentage: None


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