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Medical Device Manufacturing Supplier Quality Compliance Consultant Full-time

at QTS in Pennsylvania (Published at 11-03-2019)

Temporary, Contract

Opportunity Summary:

Excellent long-term consulting opportunity (18-24 months) to support our client?s efforts to ensure that all externally-manufactured products comply with new European Union Medical Device Regulations (EU MDR).

This will be accomplished by:

  • Mining internal Product Lifecycle Management and related systems (e.g. Adaptiv, Windchill) to evaluate existing technical files and identify gaps
  • Collaborating with suppliers to obtain details / documentation for manufacturing process information, production risk management, and direct part marking
  • Evaluating documentation against new EU MDR requirements, performing gap assessments, and collaborating with suppliers to revise existing, or develop new, documentation as applicable
  • Working with various internal client personnel to adequately update product technical files to ensure compliance with EU MDR

Ideal candidates will have solid knowledge of medical device manufacturing processes, particularly from a Compliance/Regulatory perspective. Knowledge of the applicable new EU MDR regulations and the ability to identify, prioritize, and direct/coordinate gap remediation is essential. Multiple positions available in the U.S. and E.U. with the potential for well-qualified individuals to work remotely.

Essential Functions:

  • Act as a working member of the technical file remediation team to ensure externally manufactured products meet EU MDR requirements
  • Support project deliverables, meet project timelines, resolving identified supplier issues, and execute overall technical file remediation
  • Assess supplier documentation, drawings, and process information to support project deliverables including:
  • Manufacturing Process Information
  • Production Risk Management Files
  • Validation Protocols and Reports
  • Direct Part Marking Documentation
  • Work with suppliers to meet EU MDR requirements and resolve issues with obtaining supplier product information
  • Coordinate project activities and interdependencies with other workstream and project teams
  • Partner with internal Supply Chain group to support EU MDR supplier communications and rollout of EU MDR Supply Chain workstream activities
  • Support the definition and clarification of EU MDR supplier-related process requirements
  • Support review and approval of EU MDR Change Management projects
  • Support Supplier Quality functional impact assessments
  • Support review and approval of supplier Process Validation protocols and reports
  • Support the update of supplier-related inspection criteria

Qualification Requirements:

  • Minimum of 3 years? experience as a Supplier Quality Engineer, Supplier Process Validation Engineer, Project Engineer, Project Manager, or equivalent role within the Medical Device manufacturing industry
  • Solid grasp of Supplier Management and Process Validation/Verification procedures and execution
  • Strong background in Medical Device Regulatory Compliance/Regulatory Affairs
  • Ability to act as a subject matter expert (SME) in supplier business processes
  • Proven experience with medical device technical files
  • Familiarity with ISO-13485 and FDA QSR
  • Experience working with suppliers globally across multiple sites
  • Experience with Project Lifecycle Management software (PTC Windchill, Adaptiv) a plus
  • Minimum Bachelor?s degree or equivalent in engineering or associated technical field is required

Desired Soft Skills:

  • Excellent organizational and project management capabilities
  • Strong computer skills?ability to mine/evaluate data and identify gaps
  • Excellent written, verbal, and interpersonal communication and listening skills
  • Meticulous attention to detail
  • Ability to work independently and prioritize with limited supervision
  • Previous supervisory experience (direct or indirect) is a plus
  • Dual-fluency in English and German would be highly desirable

Job Types: Temporary, Contract

Experience:

  • Medical Device Manufacturing Compliance/Regulatory: 3 years (Preferred)
  • FDA QSR: 2 years (Preferred)
  • Device Supplier Management & Process Validation/Verification: 2 years (Required)

Education:

  • Bachelor's (Preferred)

Language:

  • English (Required)

Contract Renewal:

  • Likely

Full Time Opportunity:

  • No


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