Quality Specialist

Posting Date 1 month ago(10/27/2020 10:22 AM)
Requisition ID
2020-8031
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Med Institute Inc.
Category
Quality

Overview

This person is responsible for assuring that the quality policy and quality system are understood, implemented, and maintained at all levels of the organization. This person will work with the Director of Quality to ensure 1) duties within the quality function at MED are accomplished in a timely manner, including technically excellent QC for all MED service areas and internal audits to support MED’s Quality System, 2) the quality policy and quality system are maintained at all levels of the organization, and 3) continuous improvement in the quality function is maintained and documented.

Responsibilities

  • Develop and refine QMS documents by developing procedures, policies, guidance documents, forms, training materials, and other documentation
  • Ensure QMS processes are compliant with pertinent regulations and external standards
  • Maintain a working knowledge of QMS procedures, regulations, and standards
  • Assist in assessing quality system effectiveness
  • Train staff on QMS processes
  • Ensure compliance to Quality Management System (QMS) processes
  • Interact with colleagues at all levels with the goal of researching, problem-solving and coordinating QMS activities to ensure the system is functioning properly
  • Perform QA and QC responsibilities outlined in the QMS (e.g., review and approve protocols, reports, project documentation, validation documentation, and regulatory submissions for accuracy and compliance to applicable procedural standards and QSIs)
  • Notify Management of any issues requiring prompt attention
  • Monitor open CAPAs and evaluate their effectiveness
  • Monitor and understand updates to external standards and regulations
  • Assess impact of proposed procedural changes to QMS and other QMS documents
  • Identify additional QS accreditation and lead effort for implementation
  • Perform internal audits – assume responsibility for preparation, performance, reporting and follow-up
  • Address action items identified during audits by initiating the Corrective and Preventive Action system
  • Perform external audits and assessments of vendors, sites and other facilities and organizations as required
  • Maintain Quality records
  • Perform all responsibilities with a professional, collegial attitude

 

 

Qualifications

  • Technically qualified by education, training and/or experience
  • Minimum of B.S. degree, preferably in engineering or science, 3 years of relevant experience preferred
  • Extreme attention to detail
  • Computer skills including word processing and spreadsheets
  • Previous experience with quality systems a plus
  • Ability to present a professional and personable demeanor in interactions with others
  • Proven ability to communicate and work constructively with colleagues
  • Conscientious person with good work ethic
  • Personal discipline with excellent initiative and ability to take independent action
  • Ability to work with multiple persons, changing priorities and fluctuations in work load
  • Excellent written and verbal communication skills to effectively communicate with professionals from a wide range of backgrounds and education levels
  • Good listener
  • Ability to maintain group perspective
  • Sufficiently assertive to deal professionally with minimally confrontational situations
  • Excellent organizational skills and prioritizing skills
  • Ability to read and evaluate information to determine compliance with standards and legislation
  • Ability to remain independent of areas being audited/reviewed
  • Ability to understand and follow checklists
  • Experienced or trained in auditing techniques, including successful completion of an internal auditing course
  • Ability to become knowledgeable of and operate within:
  • MED Institute and its operation
  • Applicable procedures
  • Applicable regulations
  • Quality System standards (ISO 13485, ISO 14155, ISO/IEC17025)
  • Filing system requirements for involved systems
  • Document formatting requirements

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