Quality Engineer

Job Description:

• Directly support product realization from material acquisition to product build/test/release to delivery/service to returns.
• Provide day-to-day direction of technicians/inspectors and engineers. 
• Activities include CAPA execution, complaint investigation, inspection and test method development, implementation of manufacturing process controls including process validation, sterile load prep and release and risk management. 
• This role will execute and finalize special projects to continuously improve product and process quality as well as quality system improvements.

Job Responsibilities:

• Prioritize incoming, in-process, and final acceptance testing to meet Quality Standards and Business needs.
• Develop Inspection Procedures in collaboration with Technicians/Inspectors, Supplied Quality, Sustaining and Development groups as applicable.
• Review Quality Records for accuracy and completeness.
• Create and maintain control plans for products that includes inspection from components through finished goods.
• Resolves first level manufacturing and technical issues in a timely manner via NCR process.
• Work with cross-functional leadership in identifying, prioritizing, communicating, and resolving quality issues and opportunities for improvement.
• Maintain NCR Trending metrics to identify opportunities for improvement.
• Perform Sterile Load preparation and release.
• Assists with returns decontamination, complaint investigation/analysis and final release of sterile products including collaboration with contract manufacturers as applicable.
• Performs process validation planning and execution, revalidation assessments.
• Assists withb design transfer of new product into production

Skills:

Quality engineering, Root cause analysis, CAPA, ISO 13485, Quality assurance, design transfer, NCR

Additional Skills & Qualifications:

• Bachelor's Degree
• 2+ years experience in Quality Assurance within the medical device industry
• Knowledge of medical device regulations and standards:
  • FDS QSR (21 CFR Part 820)
  • Health Canada (CMDR)
  • ISO 13485
• Experience with MiniTab including Measurement System Analysis (Gage R&R, Attribute Agreement Analysis), charting, normality, capability analysis etc.
• Experience using Agile Product Lifecycle Management (strongly preferred but not required)
• Strong attention to deatail and experience with Good Documentation Practice (GDP)
• Demonstrated proficiency with MS Office and Adobe Acrobat