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Sr. Quality Engineer

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    Other Locations

  • Salary


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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

Austin Vita is acting as an Employment Agency in relation to this vacancy.

Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.