Allentown
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Role: Daily Complaint Volume Specialist Location: West Chester, PA Duration: 9 month contract Daily Complaint Volume Specialists Receives daily product complaints (intake), works phones, distributing necessary forms for request for information and entering complaints into client Complaint Handling System (CatsWeb). Understands and has been part of the Complaint Handling process within a Medical De...
Role: Project Lead Location: West Chester, PA Duration: 7 month contract Generates daily, weekly, and monthly status reports. Lead team of 10 to 15 CAPA, Legacy Review type Consultants at multiple sites Able to provide status updates of team to MC&QS Subgroup Lead and WS Lead. - 5+ years of experience - Understanding of MS Project - MS Office (Word, Excel) guru - Strong organizational, personnel a...
As an experienced Manufacturing Engineer within the Medical Device industry, the engineer will be providing guidance and conduct remediation activities related to Process Validation. 5+ years validation experience Test Method, Equipment, and Process Validation experience Experience writing and executing protocols including IQ,OQ,PQ,PPQ FDA regulated experience Has a good holistic understanding of...
· 5+ yrs. of experience within the Medical Device as a Supplier Quality Engineer with the following skills: · Process Validation · Project Management Skills · The level of resource will determine the managerial skill sets and ability to direct others. · Should have a strong work ethic, be able to work independently, be self-motivated and attentive to detail and deliverables. · The resource will be...
Compliance Auditors will be part of the Regulatory Compliance Work Stream. Responsible for conducting audits with focus on both standard compliance (21 CFR 820) as well as Process Compliance. 5+ yrs. experience Experience with conducting audits with focus on both standard compliance as well as process compliance Support back and front room activities during notified body audits Conduct internal au...
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