Piper Companies is currently looking for a Medical Device-Program Lead in West Chester, PA to join an innovative player in the orthopedic industry to support a long-term transformation project.
The goal is to ensure all product technical file contributions meet new EU MDR requirements. Provide updated contributions to multiple workstreams supporting aspects of the technical file. Reference EU MDR Workstreams for Key deliverables.
Responsibilities of the Medical Device-Program Lead include:
- Work with workstream leads to develop project goals, deliverables and plans for execution in 2019 inclusive of the following Workstreams:
- Packaging & Labeling
- Direct Part Marking
- Quality Management Systems
- Purchase for Resale
- NPI Working Group (Manufacturing Process Development) (MDD)
- Biological Safety Requirements
- Tech File Remediation (PFMEA, PRM, MPI)
- Support the Quality Management Workstream by reviewing the Global Orthopaedic Gap assessment for Supplier Control SOPs against ISO references and revising SOPs to close gaps
- Support update of applicable Supplier Quality Procedures and Work Instructions
- Support Review and Approval of EU MDR Change Orders as applicable
- Support the NPI Working group (Manufacturing Process Development) (MPD) to shape the Global Orthopedic position and align with Notified Bodies on interpretation of EU MDR.
- Build, recruit, and manage a Supplier Quality team to meet all workstream objectives.
- Manage SQ resources to bring Technical Files into compliance with the new EU Medical Device Regulations (EU MDR, formerly known as MDD) and re-registering medical devices in the EU (Tech File input consolidation/coordination (PFMEA, PRM, MPI) with workstream inputs.
- Manage schedule adherence for SQ plans across workstreams.
- Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
- Cross coordinate Workstream activities/interdependencies with other Workstream Leads.
- Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities.
- Partner with EU MDR Supply Chain Workstream Core Team to support tracking and expediting of supplier related product codes to meet project deadlines
- Other related tasks may be assigned at the discretion of local Supplier Quality Management and/or the EU MDR Supply Chain Workstream Core Team (SQ Lead).
Qualifications for the Medical Device-Program Lead:
- 5+ years’ experience in a supervisory position, medical device/pharma exp. Preferred (Project Engineer, Quality Engineer, Project Manager)
- Working knowledge of CFR 21, ISO 13485, or GMP regulations
- Ability to manage within a matrix organization
- APICS, Six Sigma certification a plus
- Bachelor’s Degree in Engineering, Life Sciences, or related field
Compensation for the Medical Device-Program Lead position includes:
- Commensurate to experience
- Full Benefits: Cigna Healthcare, MetLife Dental, Vision, 401k after 6 months
Please send resumes to Karen Pallone at firstname.lastname@example.org
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