Supplier Quality Engineer

Onward Technologies Inc; Greater Lincolnshire; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading diagnostics company in Greater Lincolnshire is seeking a Supplier Quality Engineer to lead quality improvements and supplier evaluations. The ideal candidate will hold a bachelor’s degree in a relevant field and have 5-7 years of experience in quality assurance within diagnostics or medical devices. This role is crucial for ensuring supplier compliance with regulatory standards through audits and assessments.

Qualifications

• Bachelor’s degree or 10 years experience in diagnostics or medical device environment.
• ASQ CQA or CQE certification is a plus.
• 5-7 years total quality assurance experience.

Responsibilities

• Lead overall quality improvement of Supplier Quality system activities.
• Perform evaluations and audits of suppliers to required standards.
• Lead supplier development activities.

Skills

Leadership abilities

Quality assurance experience

Understanding of cGMP

Familiarity with FDA standards

Education

Bachelor's degree in relevant field or equivalent experience

Tools

ISO 9001

ISO 13485

Job description

Title: Supplier Quality Enginee r

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/

Onward Technologies is an Equal Opportunity Affirmative Action employer. We prohibit discrimination in decisions concerning recruitment, hiring, compensation, benefits promotions, training, termination or any other condition of employment or career development. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, veteran status, disability status or any other legally protected status.