Career Opportunities

Regulatory and Quality Project Engineer (Contract Role)

Posted on: Tuesday, June 13, 2017
Organization: R&Q
Location: Greater Philadelphia Area, PA
Description:

The Regulatory and Quality Project Engineer transforms both R&Q and the client’s business by ensuring the delivery of regulatory and quality solutions that are best practice and innovative to enable client success through delivery of superior service either individually or by leading a team. 

Key Areas of Demonstrated Competence: 5 R&Q Knowledge Areas

Depending on the individual client assignment(s), the Regulatory and Quality Project Engineer may perform the following essential duties:

  • Leads daily regulatory and quality hands-on support to clients by providing best practice and innovative solutions.
  • Leads in the drafting of complex worldwide regulatory strategies and worldwide regulatory submissions
  • Creates the development of complex Master Validation Plans using risk based approaches; leads subsequent process validation activities
  • Leads manufacturing site transfers both nationally and internationally
  • Leads Quality System Development programs as well as Quality System Improvement programs
  • Leads quality audits and audit preparation of clients
  • Leads design assurance activities: safety risk management, usability, design verification and design validation
  • Leads FDA mock audits
  • Leads acquisition due diligence activities for mergers and acquisition activities
  • Leads and provides input to guidance document committees (FDA, etc.) both in the development and interpretation of the documents
  • Leads in the definition of supplier quality specifications and other supplier qualification activities
  • Leads supplier audits
  • Leads post-market surveillance activities including complaint/MDR handling, design history file remediation, and other remediation activities as directed by an experience consultant
  • Leads recall decision making and all associated recall activities
  • Completes an effective independent review of deliverables as assigned
  • Leads a small group of team members to ensure their growth and development based upon the     team member’s goals while balancing the business' needs
  • Leads people with a high level of emotional intelligence
  • Advocates for their team members with regard to project performance issues and concerns
  • Ensures team members are fully communicated with in regards to important R&Q activities and have a conduit to share issues, concerns, process improvements, etc.

Project Resource Responsibility

  • Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
  • Communicates project risks and issues to the project lead in a timely fashion
Requirements:

Education

  • Bachelor level degree in engineering or chemistry, physics, biology or related life science, advanced degree preferred
    5-10 years related work experience.
    3 years of experience in the medical device industry required
    Consulting experience preferred

Requirements

  • Expert knowledge in three or more of the following areas and general knowledge of all areas is required:
  • Quality System Regulations (FDA, ISO13485, EU Medical Devices Directive, Canadian MDR)
    • Expert understanding of Design Controls
  • Market Clearance and strategy (510K, EU Technical Files, Canadian licensing)
  • Experience in creating and remediating DHF for electro-mechanical medical devices with embedded software, with expertise in:
    • Design input creation via new product development process and/or re-creation during DHF remediation
    • Strong understanding of applicable standards for electro-mechanical devices with embedded software (IEC 60601, ISO 10993, BS/EN 62304, etc…)
    •  Incorporating Safety Risk Management and Usability into the product development process
    • Strong ability to create a trace from design inputs to Verification and Validation.
    • Identification and Traceability
    • Integration of Labeling
    • Creation of DHF for world-wide distribution via regulatory agencies
  • Design Verification and Design Validation (Electro-mechanical devices w/ embedded Software)
    • Ability to create test procedures/protocols
    • Ability to oversee and execute testing
    • Ability to create test reports
  • Safety and risk management per ISO 14971
  • Usability per ISO 62366 and other Human Factors Standards
  • Manufacturing Process & Service Process
    • Process Validation (IQ/OQ/PQ)
    • In-line Verification Testing and Fixture qualification
    • Part Qualification
    • PFMEA
  • Computer skills required –Microsoft Office applications; statistical data analysis
  • Expert audit and report writing skills required
  • Must be willing to travel, up to 50%

Key Behaviors

Action-Oriented, Approachable, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

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