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Senior Quality Engineer, Design Assurance

We Make Life More Rewarding and Dignified
Location: Libertyville¬ 
Department: Quality¬ 


SUMMARY


As part of the Design Assurance team, the Senior Quality Engineer plays a key role in ensuring that our products are safe and effective for our customers.¬  The Senior Quality Engineer represents Quality Management as a core team member on new product development and change implementation projects, with responsibility for driving quality and compliance activities.


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This role offers many unique intellectual challenges and close, constant interaction with the Quality Management, Research & Development, Manufacturing, Regulatory Affairs, Marketing, Project Management, and Clinical Affairs teams in a dynamic, fast-paced environment.¬  There are ample opportunities to display and grow leadership capabilities in establishing best practices, driving process improvements, and mentoring others on quality issues.¬ 


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RESPONSIBILTIES



  • Guide cross-functional teams in the appropriate application of design controls in compliance with global regulatory requirements for medical devices.

  • Facilitate project quality activities addressing design and process verification / validation for new products and significant changes to existing products or processes.

  • Facilitate design FMEA, participate in process FMEA, and conduct risk assessments in compliance with ISO 14971.

  • Interface with Hollister plant and supplier Quality Engineering and Quality Assurance for new products and significant changes to existing products or processes.

  • Utilize parametric and nonparametric statistical analysis methods (ANOVA, DOE, hypothesis testing, power analysis, process capability analysis, quality control charts, regression analysis, survival analysis, measurement system analysis, acceptance sampling) to ensure products/processes are appropriately characterized and qualified prior to market release.

  • Mentor and train others on subject matters related to principles and practices of Quality Engineering.

  • Participate in internal, supplier, and external regulatory agency audits / inspections as required.

  • Ability to travel up to 15%.


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QUALIFICATIONS¬ 


Academic/Credentials/Certifications:



  • Bachelor of Science degree or higher in Engineering or Physical Sciences

  • ASQ Certified Quality Engineer and/or ASQ Certified Reliability Engineer strongly preferred

  • ASQ Certified Manager of Quality / Operational Excellence or Six Sigma Black Belt certificate is a plus


Length of experience:



  • Minimum 5 years of experience in the medical device industry with Master's degree or 8 years of experience with Bachelor's degree.¬  Background in Quality Engineering and/or New Product Development/R&D.¬  ¬ 


Specialized skills/Technical knowledge:



  • Experience with the FDA Quality System Regulation and ISO 13485 environment at a medical device manufacturer.

  • Project management training and experience.¬ 

  • Experience with product development, design controls, and risk management for medical devices (ISO 14971).¬ 

  • Desirable:¬  Advanced statistics training and experience with plastic injection molding and automated assembly processes.


Hollister is an EO employer ‚€“ M/F/Veteran/Disability
Job Req ID: 26705




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