Supplier Quality Engineer

Onward Technologies Inc; Lincolnshire (IL); On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Supplier Quality Engineer to enhance their quality systems and processes. This role involves leading supplier evaluations and audits to ensure compliance with FDA and ISO standards. The ideal candidate will have a strong background in quality assurance within the diagnostics or medical device sectors, complemented by leadership skills and relevant certifications. Join a forward-thinking team dedicated to improving supplier quality and regulatory compliance, and make a significant impact in a dynamic environment.

Qualifications

• Bachelor’s degree or 10 years of experience in diagnostics or medical devices.
• 5-7 years of quality assurance experience in diagnostics or medical device environments.

Responsibilities

• Lead quality improvement of Supplier Quality system activities and processes.
• Perform evaluations, visits, and audits of suppliers to meet standards.
• Initiate and audit Supplier Corrective Action Reports.

Skills

Leadership

Quality Assurance

Supplier Audits

Regulatory Compliance

cGMP

ISO 9001

ISO 13485

Education

Bachelor’s degree in Science, Engineering, or Health Services

10 years of experience in diagnostics or medical devices

ASQ CQA or CQE certification

Job description

Title: Supplier Quality Engineer

Location: Lincolnshire, Illinois

Note: Sponsorship is not available for this position now or in the future.

Responsibilities:

1. Lead overall quality improvement of Supplier Quality system activities, processes, and integrating systems to achieve tangible improvements for the organization.
2. Perform evaluations, visits, and audits of suppliers to meet FDA, ISO, and customer standards.
3. Lead supplier development activities to assess current and potential suppliers' ability to meet customer and regulatory 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 are essential. Reasonable accommodations may be made for individuals with disabilities to perform the essential functions.

• Bachelor’s degree or 10 years of experience in diagnostics, medical devices, or equivalent military experience. A degree in science, engineering, or health services is preferred.
• ASQ CQA or CQE certification is a plus.
• 5-7 years of quality assurance experience in diagnostics or medical device environments.
• Experience with cGMP, 21CFR820, ISO 9001, 13485, and Canadian Medical Device Regulations.

For more job opportunities, visit our careers page: http://www.onwardgroup.com/careers/zoho-submit-resume/

Onward Technologies is an Equal Opportunity Affirmative Action employer. We prohibit discrimination in recruitment, hiring, compensation, benefits, promotions, training, termination, or any employment condition. All applicants will be considered regardless of race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, veteran status, disability, or other protected statuses.