Supplier Quality Engineer

Onward Technologies Inc

$70K — $95K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in science, engineering, or health services preferred, or 10 years experience in diagnostics or medical devices.
  • ASQ Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) is a plus.
  • 5-7 years of quality assurance experience in diagnostics or medical devices.
  • Strong knowledge of cGMP, 21CFR820, ISO 9001, ISO 13485, and Canadian Medical Device Regulations.
  • Leadership abilities are essential.

Responsibilities

  • Lead quality improvement initiatives for the Supplier Quality system.
  • Conduct evaluations, visits, and audits of suppliers to meet FDA, ISO, and customer standards.
  • Drive supplier development programs to assess suppliers' compliance with customer and regulatory expectations.
  • Initiate, review, and audit Supplier Corrective Action Reports.

Benefits

  • Join a dynamic team focused on continuous quality improvement.
  • Opportunity to work with leading standards in diagnostics and medical device regulation.
  • Engagement with suppliers to enhance quality and compliance.
Full Job Description
Title: Supplier Quality Engineer

Location:
Lincolnshire, Illinois

For this position, sponsorship would not be available now or in the future.

Responsibilities:
  1. Lead overall quality improvement of Supplier Quality system activities, processes and integrating systems, leading to tangible improvements for the organization.
  2. Perform required evaluations, visits and auditing of suppliers to FDA, ISO and customer required standards.
  3. Lead supplier development activities to evaluate current and potential suppliers for their ability to meet customer and regulation expectations.
  4. Initiate, review and audit Supplier Corrective Action Reports.


Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Leadership abilities should be included. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Bachelor's degree or 10 years required experience in diagnostics or medical device environment or equivalent experience in the Armed Forces.Bachelor's degree with a specialization in science, engineering or health services PREFERRED.
  • ASQ CQA or CQE a plus
  • 5-7 years total quality assurance experience in a diagnostics or medical device environment.
  • Experienced with cGMP, 21CFR820, ISO (9001, 13485), and Canadian Medical Device Regulations


If you wish to review our other job opportunities, please go to our careers page: http://www.onwardgroup.com/careers/zoho-submit-resume/

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