Why join Stryker Looking for a place that values your unique talents Discover Stryker s award-winning culture We are proud to offer you our total rewards package which includes bonuses healthcare insurance benefits retirement programs wellness programs as well as service and performance awards - not to mention various social and recreational activities all of which are location specific Job description We are excited to be named one of the World s Best Workplaces by Fortune Magazine We are proud to offer you our total rewards package which includes bonuses healthcare insurance benefits retirement programs wellness programs as well as service and performance awards - not to mention various social and recreational activities all of which are location specific What will you do Primarily responsible for Risk management and risk assessment as per ISO 14971 Risk Table creation Analysis FMEAs Quality Plan Literature Review Device Master Record Quality Training Plan and Technical File Primary participant in new supplier selection validation and contract development Assists vendors in resolving manufacturing and quality issues as required Partners with the operations team to develop and maintain a robust internal and external supply chain Develop procedures for incoming in-process and final inspections for current product development Assists Leads in the trending and analysis of quality data e g complaints scrap warranty return rate etc and provides guidance to address issues as appropriate Authors and reviews procedures to ensure GMP and ISO 13485 compliance and provide inputs for NPDP for adherence to QMS along with good documentation practices Lead product quality related projects Supports the business in addressing and solving quality problems Support process validation programs for new product development Work with engineering manufacturing teams to develop robust verification test strategies to ensure product safety and reliability What you need Basic Qualifications Bachelors in mechanical or biomedical or Biotech Engineering Good understanding of Quality Management Systems ISO 13485 21 CRF 820 Minimum 2 to 6 years of relevant work experience Experience in the NPD process and various phases of new product development Knowledge of ISO 14971 IEC 62366 60601-1 family of standards Preferred Qualifications Good analytical and problem-solving skills Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams Expert-level knowledge of current industry standards for New Product Development and risk management practices Excellent communication and presentation skills Must have delivered multiple projects in AQE function and understand Risk Management processes in depth Stryker is a global leader in medical technologies and together with its customers is driven to make healthcare better The company offers innovative products and services in MedSurg Neurotechnology Orthopaedics and Spine that help improve patient and healthcare outcomes Alongside its customers around the world Stryker impacts more than 150 million patients annually