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Sr. Quality Engineer

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    Alex Williams

  • Published

    18 days ago


Quality Engineer / Sr. Quality Engineer

Position Summary:
We are seeking a hands-on Quality Engineer with experience in medical device manufacturing

Essential Functions:
* Supports the establishment, implementation, and maintenance of the quality system in
compliance with FDA, ISO, and other regulations, standards, and internal procedures
* Monitors and measures the performance of the quality system while driving quality system
* Provides hands-on technical and quality support for new product development and ongoing
manufacturing activities
* Formulates inspection instructions and methods for receiving, in-process, and final inspection
* Engages in the execution of product and process validation protocols and the writing of validation
* Directs quality planning and risk management activities for new and modified products as part of
the design control process
* Manages supplier quality, supplier audits, and oversees the investigation and corrective actions
related to supplier quality issues.
* Manages the complaint-handling system and maintains compliance with FDA and international
adverse event reporting requirements
* Manages the Corrective/Preventative Action system and oversees timely completion of corrective
actions related to complaints, internal audits, vendor audits, management reviews,
nonconformance reports and other sources
* Oversees product sterilization validations, clean room monitoring, and microbiological activities
* Uses statistical tools to analyze data, make acceptance decisions, and improve process capabilities
* Routinely trend quality indicators and issue reports to USGI Management
* Participate in internal, FDA, and Notified Body surveillance audits
* Initiate and/or review document changes for impact on device safety and efficacy, as well as
compliance with quality system requirements

Qualifications & Skills:
* Thorough knowledge of Quality systems and processes including GMP, QSR, and ISO requirements
* In-depth knowledge and experience with quality system and quality engineering processes
including risk management, complaint handling, CAPA, NCR management, design control,
manufacturing quality support, and quality metrics
* Self-directed with ability to get things done
* Ability to anticipate and proactively mitigate project risk
* Proficient in use of statistical tools
* Detail-oriented with strong problem-solving skills
* Excellent written and verbal communication skills

Education & Experience:
* Bachelor's Degree in engineering
* Minimum 3 or more years' related experience in the medical device industry