Sr Quality Engineer - #7504635

Our brand promise

We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.

• Remarkable service A seamless, personal process designed around you and your needs.
• Trusted performance Our product family is the result of years of experience championing surgeons and listening to their expertise.
• Outstanding value No matter the surgical specialty, we deliver quality products for all markets.
  
  

Our people promise

Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.

Job Purpose Summary

The Senior Quality Engineer will provide support and direction in quality assurance, control and preventative activities with a focus on sustaining products. Manages the execution and changes in quality activities related to process development, verification, validation and manufacturing transfer while ensuring compliance to regulations and standards.

What You Will Do

[Job Responsibilities – bullet points]

• Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional
• Monitor and maintain the quality system to comply with all applicable regulatory requirements including FDA QSRs, ISO, Medical Device Directive and other applicable standards and/or guidelines
• Design and perform product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions
• Works closely with operations and the business functions to ensure quality performance of product and processes
• Maintains KPIs for monitoring of process and/or product quality, performs analysis, and interprets trends. Leads process improvements
• Review non-conformance reports and materials with production and engineering personnel to identify corrective actions
• Participates in the development and review of process and equipment validation/qualification and MSAs.
• Executes internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes
• Review manufacturing processes to develop preventive actions
• Direct the tracking and statistics of defects, test results or other regulatory quality data.
• Review and approve validation / qualification, Material Reports and other QA documents for compliance with business practices and departmental procedures and policies
• Performs other related duties as assigned or required
  
  

What you will need

• Degree in Engineering (Mechanical or Electrical preferred) or equivalent certification and work experience
• Minimum of 5+ years of working experience in engineering, quality or manufacturing within a medical device company
• Strong validation understanding
• Automation background preferred
• Experience using MS Office Suite products (Word, Excel, PowerPoint, and Outlook)
• Strong time management skills to ensure prioritization and organization to meet deadlines of multiple projects
• Experience problem solving and lean principles
• Strong communication skills. Must be fluent in Spanish and English.