MDR Supplier Quality Engineer
POSITION DUTIES & RESPONSIBILITIES:
Project Name: European Union Medical Device Regulation (EU MDR) Supplier Quality (SQ) Extended Team Member Support
The EU MDR SQE will evaluate the supplier’s manufacturing process information, production risk management, direct part marking documentation against MDR Requirements; collaborate with the supplier to revise existing or develop new manufacturing process information, production risk management and/or direct part marking documentation as applicable.
Scope of Work to include the following:
Become a working member of the technical file remediation efforts to ensure externally manufactured DePuy Synthes products meet EU MDR requirements. This includes supporting project deliverables; meeting project timelines; resolving identified supplier issues and executing the overall project related to technical file remediation requirements.
Assess supplier drawings and process information to support project deliverables:
• Manufacturing Process Information
• Production risk management file o Validation protocols and reports
• Direct part marking documentation
Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.
Cross coordinate Workstream activities/interdependencies with other workstream and project teams.
Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities;
• Support definition and clarification of EU MDR supplier related process requirements.
• Support Review and Approval EU MDR Change Projects as applicable.
• Support Supplier Quality Functional Impact Assessments as applicable.
• Support Review and Approval of supplier Process Validation Protocols and Reports as applicable. Support the update of supplier related Inspection Criteria as applicable.
EDUCATION & EXPERIENCE REQUIREMENTS:
• A minimum of a bachelor’s degree or equivalent in engineering or associated technical field is required.
• A minimum of 3 years’ experience in a quality engineering is required.
• A minimum of 2 years’ experience in the medical device and/or pharmaceutical industry is required. Familiarity with ISO 13485 and FDA QSR is required.
• Excellent organizational skills and attention to detail is required.
• Must be able to work independently and prioritize with limited supervision.
• Strong written and oral communication and interpersonal (listening) skills.
• Excellent computer, communication, and written skills are required. Proficient in Microsoft Office suite is required.
EXPERIENCE & KNOWLEDGE PREFERRED:
• Three years’ experience as Supplier Quality engineer;
• Supplier Process Validation engineer;
• Project Engineer, Project Manager or equivalent role within regulated industry.
• Understanding supplier management and validation procedures and execution.
• Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.
• Experience working with suppliers across multiple sites and franchises.
• Ability to act as an SME in supplier business processes.
• Experience with medical device technical files