Quality Engineer

Organization
Aldevron
Job Location
Fargo, ND 58102
Benefits

Health, Vision, Dental, Life, Long and Short Term Disability, 401k w/match, FSA/HSA, PTO

Job Description

Position Summary:

The Quality Engineer is responsible for supporting activities related to the implementation, maintenance and continuous improvement of Aldevron's electronic quality management system (eQMS) (i.e. AssurX). This role supports the eQMS user needs and requests. This role provides technical assistance for planning, organizing, designing and implementation of the modules within the eQMS for release for use within a regulated environment. This role assists with the administration of Quality records within electronic systems such as AssurX and NetSuite.

Essential Duties and Responsibilities:

  • Support quality system programs, processes and facilities by ensuring compliance with internal, regulatory, and client requirements in the manufacture of products.
  • Support qualification and validation activities through review, approval, and/or execution of qualification protocols, reports, and associated records.
  • Support the change control process through identification, implementation, verification, and closure of required changes in collaboration with the CCR Board.
  • Support the CAPA system by ensuring events are adequately investigated, documented and communicated; appropriate CAPAs are identified and implemented; and, all records are closed on time.
  • Perform effectiveness verifications and trending assessments.
  • Compile, distribute and report management review data in support of Quality Systems Management Review. 
  • Perform internal audits, manage the internal audit schedule, and oversee identified corrective and preventive action requirements.
  • Assist with supplier qualifications, perform supplier evaluations (e.g. on-site audits), manage the supplier audit schedule, and oversee identified corrective action requirements.
  • Modify and customize the eQMS to improve functionality and efficiency.
  • Support activities related to the development of new system process workflow customization and capability alternatives within the eQMS.
  • Support users of eQMS in troubleshooting and password resets; conduct new hire/user access training for the eQMS.
  • Support continuous improvement projects addressing process efficiency, costs and performance.
  • Assist with inspection readiness activities including audit/SME preparation.
  • All employees are responsible for the general upkeep of work and shared spaces.
  • Other duties as assigned.
Requirements

Qualifications:

Experience:

  • At least 3 years Quality Systems or Regulatory Compliance experience in a GxP environment.

Education:

  • Bachelor's (or equivalent) degree in science or related field.

Skills and Knowledge:

  • Excellent oral communication and technical writing skills.
  • Strong analytical skills.
  • Knowledge of GxP regulations and guidelines. 
  • Knowledge of ISO certification and requirements.
  • Applicable ASQ certifications, highly desired.

Abilities:

  • Ability to interface effectively and professionally at all levels.
  • Ability to apply statistics and metrics to process improvement models.
  • Ability to work on cross functional teams and apply influencing skills in a matrix environment.

Personal Characteristics:

  • Demonstrated high ethical standards and trustworthiness.
  • Demonstrated leadership and organization skills.
  • High attention to detail.

Working Conditions:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers/filing cabinets and fax machines.

Physical Requirements

 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use arms, hands and fingers for various activities.  This position may stand or remain sedentary for long periods of time.


How to Apply

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://www.applicantpro.com/j/596062-149639 

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