LINQM needs to add 2 Principal Packaging Engineers to the team.

Skills: - Expert knowledge with ISO11607, ASTM & AAMI previous and current standards.

- Experience and knowledgeable with EU MDR requirements specific to packaging related changes.

- Experience with packaging related Regulatory submission for EU MDR requirements.

- Knowledgeable with packaging Process qualification, Design Verification and Shelf life requirements.



Experience with: CLINICAL TRIALS, DOCUMENTATION, PACKAGE DESIGN, PROCESS DEVELOPMENT, PROJECT PLANS, TECHNICAL DOCUMENTATION, and PROTOTYPE

Provide packaging, quality compliance, and regulatory expertise for THV Packaging against EU MDR requirements in support of necessary regulatory submissions and on-going validation/verification programs.

Provide support for THV Packaging MDD/MDR program including but not be limited to:

Research and document packaging gap assessments for sterile and non-sterile packaging configurations.

Review existing Design Verification documentation and associated attachments.

Review existing Stability (Aging) documentation and associated attachments.

Review existing Installation Qualification (IQ), Operational Qualification (OQ), and Performance/Process Performance Qualification (PQ/PPQ) documentation and associated attachments.

Revise/create packaging related documentation including but not limited to protocols, reports, technical summaries, and other documents as needed to support ongoing regulatory efforts.

Provide support for Cleaning and Sterilization validations and qualifications, including but not limited to protocol and report creation and review, gap assessments, and on-going validation follow-up.

Creation and review of Risk Management documentation including but not limited to FMEAs, Risk Management Plans (RMPs), and Risk Management Reports (RMRs).

Other technical support related to ongoing Regulatory MDD/MDR projects.

Training on Edwards document control system and/or any other training required to complete the activities required

Collaborate with Edwards team members while working independently on review and document generation activities, as well as other regulatory support activities.

Deliverables:  May include but not limited to:

Including but not limited to written Gap Analyses, Compliance Assessments, Protocols, Reports, and other documentation required to support the activities as described in section 2.1.