We are seeking a Supplier Quality Engineer with medical device industry experience to support supplier quality management component qualification and supplier development activities. This role will be responsible for ensuring suppliers consistently meet quality regulatory and performance requirements with a strong focus on PCB components testing methodologies and supplier qualification processes.
The ideal candidate will have experience working with medical device suppliers PCB assemblies PPAP processes supplier audits and quality systems within FDA-regulated environments.
Key Responsibilities
Lead supplier selection qualification and performance monitoring activities
Manage supplier onboarding and component qualification processes including PPAP submissions and approvals
Partner with suppliers to establish and evaluate PCB testing methods inspection criteria and acceptance standards
Review and validate functional electrical and verification testing processes for PCB components and assemblies
Ensure supplier processes and products meet design quality and regulatory requirements
Conduct supplier audits (onsite and remote) and drive corrective and preventive actions
Support development validation and continuous improvement of test methods and inspection processes
Collaborate with Engineering Manufacturing Quality and Supply Chain teams to support design transfer and manufacturing readiness activities
Participate in DFMEA and risk management activities to identify and mitigate supplier-related risks
Monitor supplier quality performance metrics and drive continuous improvement initiatives
Required Qualifications
Bachelors degree in Engineering Quality or related technical discipline
Experience in Supplier Quality Engineering within the medical device industry
Strong knowledge of supplier qualification component validation and PPAP processes
Experience with PCB components assemblies and testing methodologies
Experience conducting supplier audits and managing supplier corrective actions
Understanding of design verification validation and risk management processes
Strong problem-solving communication and project management skills
Job Title: Supplier Quality Engineer Location: Burnsville MN Duration: 9 Month Contract (Potential Extension) Start Date: ASAP Position Overview We are seeking a Supplier Quality Engineer with medical device industry experience to support supplier quality management component qualification and su...
We are seeking a Supplier Quality Engineer with medical device industry experience to support supplier quality management component qualification and supplier development activities. This role will be responsible for ensuring suppliers consistently meet quality regulatory and performance requirements with a strong focus on PCB components testing methodologies and supplier qualification processes.
The ideal candidate will have experience working with medical device suppliers PCB assemblies PPAP processes supplier audits and quality systems within FDA-regulated environments.
Key Responsibilities
Lead supplier selection qualification and performance monitoring activities
Manage supplier onboarding and component qualification processes including PPAP submissions and approvals
Partner with suppliers to establish and evaluate PCB testing methods inspection criteria and acceptance standards
Review and validate functional electrical and verification testing processes for PCB components and assemblies
Ensure supplier processes and products meet design quality and regulatory requirements
Conduct supplier audits (onsite and remote) and drive corrective and preventive actions
Support development validation and continuous improvement of test methods and inspection processes
Collaborate with Engineering Manufacturing Quality and Supply Chain teams to support design transfer and manufacturing readiness activities
Participate in DFMEA and risk management activities to identify and mitigate supplier-related risks
Monitor supplier quality performance metrics and drive continuous improvement initiatives
Required Qualifications
Bachelors degree in Engineering Quality or related technical discipline
Experience in Supplier Quality Engineering within the medical device industry
Strong knowledge of supplier qualification component validation and PPAP processes
Experience with PCB components assemblies and testing methodologies
Experience conducting supplier audits and managing supplier corrective actions
Understanding of design verification validation and risk management processes
Strong problem-solving communication and project management skills