Quality Engineer in Huntington, WV at APEX Systems

Date Posted: 11/8/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/8/2019

Job Description

Job #:  1024774
Apex Systems is currently hiring a Lab Equipment Quality Engineer for a client of ours in Huntington, WV.  For more information, please reach out to Cassie Miller and cmiller@apexsystems.com
The role of the Lab Equipment Management Quality Engineer is to maintain the equipment and methods used in the Huntington QA Lab in a validated and compliant state.
Responsibilities:
  • Manage and/or execute qualifications for lab equipment and test methods. Including Equipment Qualification, Equipment Calibration Management, System Methods Validation, Qualification Documentation Management, Equipment Decommissioning (System Retirement)
  • System Administration of Laboratory Equipment including: User Access Management for Stand-Alone Systems, Technical Audit Trail Review, Providing 1st level Support, Lab Systems Access review, and Lab Systems Configuration Management
  • Support and/or lead Lab projects for new systems or equipment identification, procurement, qualification, and release
  • Lab Systems Incidents and Problem Management including Investigation of Equipment Deviations and management of Equipment Preventative and Corrective Maintenance activities. This may include management of equipment consumables.
  • Ownership of the Business Continuity Plan for Lab Equipment as well as Backup and Restore Management for Stand-Alone Systems

Education Requirements:
  • Bachelor's degree in a Science or Engineering related field. 
  • Master's degree in a Science or Engineering related field. 
  • Any Bachelor’s degree with one certification (ASQ CQA, or ASQ CQE, or RAB ISO) and more than 3 years pharmaceutical/medical device experience
  • 1-3 years in a medical device/ pharmaceutical manufacturing environment or applicable industrial experience.
  • Prefer experience with Lab Methods, GDP, CSV, Data Integrity, Deviation Investigation, and Equipment Qualifications

Additional Requirements:
  • Knowledgeable of and able to interpret the applicable statutory requirements such as QSR/GMP (parts 11, 803, & 820). ISO 13485, ISO 14001, JPAL, CMDR, AAMI, ANSI, MDD and Corporate.
  • Ability to work with specific computer software such as Microsoft Office Products, including but not limited to Word, Excel, PowerePoint, Outlook, Internet explorer.
  • Excellent oral and written communication skills for communicating audit findings and/or information.

Excellent interpersonal skill since the individual will be working with people from all skill levels within the facility.
 
 
 
 
 
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.