Senior Quality Engineer/ QE - Gurugram - Stryker Corporation

Date de publication : 9/20/2019

Résumé de l'offre

Description de l'offre

Who we want:

  • 2+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
  • Must understand the fundamentals of at least one of the following sterilization techniques: gamma irradiation, ethylene oxide (preferred), hydrogen peroxide gas plasma, moist heat, or dry heat and be an expert in one of the techniques.
  • Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures.
  • Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives.
  • Ability to effectively work cross-functionally with Product Development, Operations and Marketing.
  • Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
  • Demonstrated ability to technically mentor associate engineers and scientists.
  • Must understand the fundamentals of moist heat, gamma irradiation, and ethylene oxide sterilization.
  • Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
  • Experience in working in a compliance risk situation.
  • Demonstrated experience with bio-compatibility tests, ability to interpret the associated industry guidelines.
  • Prefer demonstrated competency in advanced testing technologies.

What you will do

  • Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopedic implants and surgical instruments.
  • May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
  • Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
  • Participate in the development and improvement of the manufacturing processes for existing and new products.
  • Support product transfers to other plants/facilities. 
  • Review/approve nonconforming material and system documentation.
  • Review/approve product and process change control documentation and specifications.
  • Actively participate on teams to support new product development activities.
  • Support design verification and validation test requirements that ensure appropriate objective evidence is available to support acceptance criteria.
  • Participate in design reviews by identifying risks associated with the product use and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
  • Implement data analysis and statistical techniques to drive appropriate risk management activities and prioritization of issues.    
  • Ensure effective implementation and compliance to all applicable regulations and standards, including 21CFR820, ISO 13485, ISO 14971 throughout the design and development process.

Education:

M.Sc. in Microbiology

Work From Home: Yes

Travel Percentage: 10%

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