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MDR Supplier Quality Engineer ( Remote)

Company:
Lancesoft Inc.
Location:
West Chester, Pennsylvania, United States
Posted:
October 17, 2019

Description:

Description:

MDR Supplier Quality Engineer

POSITION DUTIES & RESPONSIBILITIES:

Project Name: European Union Medical Device Regulation (EU MDR) Supplier Quality (SQ) Extended Team Member Support

Deliverables:

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