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Senior Quality Engineer, Sterilization
Job#: 18QA-O1
Positions: 1
Posted: 04/21/2017
Job Type: Full Time
Location: Danvers, MA
Department: Quality
Contact: Pam Hinckley
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Job Description

Job Description:

The Senior Sterilization Quality Engineer is responsible for managing the Environmental, Microbiology and Sterilizations systems and practices through the implementation of the appropriate Medical Device standards. The candidate will be the subject matter expert in these areas and coordinate all activities related to them across the organization.

 

Principle Duties and Responsibilities:

  • Facilitates the timely completion of quarterly Dose Audits, monthly Bioburden and annual re-certification process for all sterilization modalities.
  • Works closely with engineering investigation teams to assure the timely closure of technical investigations.
  • Front room ISO and FDA compliance audits;
  • Knowledge of AAMI ST72, ISO 11135, ISO 11137, ISO 11737-1, ISO 10993-7, AAMI ST72
  • Works with R&D, manufacturing and quality to bring new product and changes to existing products to completion as the sterilization SME.
  • Coordinates  monthly quarterly and annual  environmental monitoring testing
  • Responds to Request from Regulatory bodies for supplemental information or clarification of existing submittals.
  • Works with sterilization vendors in order to resolve ay non-conformances
  • Identify and implement improvements to the environmental monitoring and sterilization systems
  • Prepare metrics and trending reports for Sr. Management on a monthly basis.
  • Provide direction regarding Corrective and Preventative Actions that relate to the product microbiology, sterilization and environmental monitoring.
  • Interprets updates to applicable international standards and guidelines and implements them into the quality system.
  • Validate clean room
  • Assist management on departmental projects, as necessary.
  • Help investigate issues with Manufacturing daily 
  • Other duties as specified.
Skills/Requirements

Job Qualifications:

 

  • Bachelor and Engineering degree required
  • 5 years of quality engineering work experience in a regulated environment. Medical device experience preferred
  • Knowledge of lean, six sigma, kaizen and continuous improvement initiatives a plus
  •  Excellent verbal and written communication skills
  • Strong organizational skills; must be detailed-oriented
  • Ability to execute tasks in a timely manner under general supervision
  • Strong knowledge of Microsoft Office Suite and Adobe Acrobat
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