The Career Management Group
Direct message the job poster from The Career Management Group
Supplier Quality Engineer Location: Melville, NY
Position Description
The Supplier Quality Engineer ensures supplier compliance with regulatory standards through audits, monitoring, and on-site root cause analysis. They implement corrective actions, track supplier quality metrics, and lead initiatives to improve the Quality Management System. This role involves reviewing customer complaints, conducting product investigations, and handling medical device reporting assessments. The ideal candidate has experience in supplier management and FDA‑regulated industries, particularly in medical devices, with proficiency in relevant regulations and standards. Strong communication, teamwork, and problem‑solving skills are essential.
Primary Responsibilities
Perform regular supplier audits to ensure regulatory compliance.
Monitor and improve supplier quality and process performance.
Facilitate and perform on‑site visits for root cause analysis.
Implement and verify corrective actions of supplier quality issues.
Create, monitor, and present supplier quality performance metrics.
Maintain accurate quality records for supplier management.
Develop new approaches to solve problems identified during quality assurance activities.
Assists or leads activities/projects to improve the Quality Management System, including coordinating, development, training, and maintenance.
Review customer complaints, conduct product investigations, and ensure proper complaint closure.
Conduct medical device reporting assessments and process potential MDR reports.
Ideal candidate should possess good problem‑solving & logical decision‑making abilities.
Develop sampling plans for evaluating and reporting quality and reliability data.
Demonstrate continuous effort to improve product quality and manufacturing processes.
5-7 years in manufacturing industry in Quality functions in an FDA regulated or equivalent industry. Experience in medical device industry highly desirable. Experience in Supplier Management.
Working knowledge of FDA regulations, cGMP, US‑FDA’s 21 CFR part 820, and ISO 13485:2016.
Strong MS Office skills.
Excellent communication, interpersonal skills, teamwork and problem‑solving skills.
Travel approximately 30%.
Education Requirements
Bachelor's degree in Engineering preferred.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance, Engineering, and Supply Chain
Industries
Medical Equipment Manufacturing and Engineering Services
#J-18808-Ljbffr
Supplier Quality Engineer Location: Melville, NY
Position Description
The Supplier Quality Engineer ensures supplier compliance with regulatory standards through audits, monitoring, and on-site root cause analysis. They implement corrective actions, track supplier quality metrics, and lead initiatives to improve the Quality Management System. This role involves reviewing customer complaints, conducting product investigations, and handling medical device reporting assessments. The ideal candidate has experience in supplier management and FDA‑regulated industries, particularly in medical devices, with proficiency in relevant regulations and standards. Strong communication, teamwork, and problem‑solving skills are essential.
Primary Responsibilities
Perform regular supplier audits to ensure regulatory compliance.
Monitor and improve supplier quality and process performance.
Facilitate and perform on‑site visits for root cause analysis.
Implement and verify corrective actions of supplier quality issues.
Create, monitor, and present supplier quality performance metrics.
Maintain accurate quality records for supplier management.
Develop new approaches to solve problems identified during quality assurance activities.
Assists or leads activities/projects to improve the Quality Management System, including coordinating, development, training, and maintenance.
Review customer complaints, conduct product investigations, and ensure proper complaint closure.
Conduct medical device reporting assessments and process potential MDR reports.
Ideal candidate should possess good problem‑solving & logical decision‑making abilities.
Develop sampling plans for evaluating and reporting quality and reliability data.
Demonstrate continuous effort to improve product quality and manufacturing processes.
5-7 years in manufacturing industry in Quality functions in an FDA regulated or equivalent industry. Experience in medical device industry highly desirable. Experience in Supplier Management.
Working knowledge of FDA regulations, cGMP, US‑FDA’s 21 CFR part 820, and ISO 13485:2016.
Strong MS Office skills.
Excellent communication, interpersonal skills, teamwork and problem‑solving skills.
Travel approximately 30%.
Education Requirements
Bachelor's degree in Engineering preferred.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance, Engineering, and Supply Chain
Industries
Medical Equipment Manufacturing and Engineering Services
#J-18808-Ljbffr