Quality Engineer
A Medical Device packaging company in the Philadelphia area is looking for a Quality Engineer.
This person will be involved in all things quality assurance including reviewing customer complaints, engaging with customer and performing root cause analysis/audits.
They will also be involved in determining and implementing corrective action.
They will perform FMEAs, perform risk mitigation projects, identify and report quality related trends and implement systems to detect trends.
They will have daily engagement with production and team leads to ensure proper compliance to standards and regulations (specifically medical related ISO standards such as 13485).
They could be involved in writing procedures and reviewing change overs.
They will also be involved in validations and ensuring the proper alignment of inputs and outputs.
Close attention to detail and strong communication skills are a must.
Packaging Related background Medical related backgroundBachelors Degree in Engineering or related field 3
years in quality related role Strong problem solving skills Comfortable working on the manufacturing floor and communicating with various manufacturing departments Experience with root cause analysis and implementing corrective action Prior experience working in a highly regulated environment (understanding of ISO 13485 is a big plus) Strong written and verbal communication skills Recommended Skills Attention To Detail Auditing Communication Corrective And Preventive Action (Capa) Engineering Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
This person will be involved in all things quality assurance including reviewing customer complaints, engaging with customer and performing root cause analysis/audits.
They will also be involved in determining and implementing corrective action.
They will perform FMEAs, perform risk mitigation projects, identify and report quality related trends and implement systems to detect trends.
They will have daily engagement with production and team leads to ensure proper compliance to standards and regulations (specifically medical related ISO standards such as 13485).
They could be involved in writing procedures and reviewing change overs.
They will also be involved in validations and ensuring the proper alignment of inputs and outputs.
Close attention to detail and strong communication skills are a must.
Packaging Related background Medical related backgroundBachelors Degree in Engineering or related field 3
years in quality related role Strong problem solving skills Comfortable working on the manufacturing floor and communicating with various manufacturing departments Experience with root cause analysis and implementing corrective action Prior experience working in a highly regulated environment (understanding of ISO 13485 is a big plus) Strong written and verbal communication skills Recommended Skills Attention To Detail Auditing Communication Corrective And Preventive Action (Capa) Engineering Iso 13485 Estimated Salary: $20 to $28 per hour based on qualifications.
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