Quality Engineer

Job Title
Quality Engineer
Job ID
27736108
Location
Durham,  NC 27709
Other Location
Description
Job Summary:
The Quality Engineer will be responsible for assisting in the development and implementation of the quality system of the company while providing support to product development, operations/manufacturing, and manufacturing engineering.

Essential Duties and Responsibilities:
  • Develop and maintain strong, internal working relationships across both North and South restor3d facilities
  • Understand the objectives, responsibilities, and mission of the Engineering department and work towards those goals
  • Prioritize and plan work activities; adapt for changing conditions
  • Assisting in the development of the company quality system to support medical device offerings and operations and ensure continual improvement in quality. This may include drafting and reviewing quality system documents as necessary, managing document change requests, and regularly reviewing procedures for accuracy and appropriateness.
  • Participating in assigned project teams by providing expert guidance on Restor3D processes/procedures.
  • Assisting with quality system implementation including, but not limited to:
    • Reviewing, approving, and aiding in the creation of R&D design control documents such as:
      • Product Development Quality Plan
      • Design Input / Output Document
      • Risk Management documents such as DFMEA and PFMEA
      • Verification & Validation Plans and Test Protocols 
      • Engineering Drawing Review
    • Participating in phase review meetings
    • Ensuring consistency across all 510(k) clearance projects
    • Audit and approve custom product documentation to ensure FDA compliance
    • Continuous Improvement projects for the Design Controls system
    • Supporting the drafting and execution of IQs, OQs, and PQs
    • Assisting in product failure and root cause investigations
    • Contributing to design history files and other design deliverables
    • Supporting the review and release of custom designed implants
    • Generally assuring adherence to all company quality procedures
  • Support the CAPA process by:
    • Managing assigned CAPAs and support other CAPA teams as assigned by:
      • ensuring CAPAs are generated appropriately, corrective actions are implemented, performing effectiveness checks and CAPA are closed per scheduled timelines
      • assessing for systemic issues based on overall CAPA data and formulating and implementing process improvement changes as necessary.
  • Initiate, review, and perform root cause(s) investigations for nonconformities related to the processes and/or quality system, identifying actions(s) needed to correct or prevent recurrence, verifying and validating the action(s) to ensure effectiveness, implementing, and recording changes to processes needed to correct/prevent nonconformities, and disseminating information related to nonconformities to those directly responsible.
  • Support the document management program (e.g., policies, standard operating procedures, forms) including creating or developing document content requirements, change and approval needs, communication of critical changes, and providing final approval of documents as assigned.
  • Assisting with quality system maintenance including, but not limited to:
    • Supporting Continuous Improvement projects for the Design Control system
    • Reviewing and approving production lot history records
    • Assisting with and documenting regular management reviews
    • Generally assuring adherence to all company quality procedures
  • Participate in hosting inspections by regulatory authorities (e.g., FDA) and ensure all observations are appropriately addressed
  • Other responsibilities as assigned


Qualifications:
  • Bachelor’s degree (B.S.) in engineering from a four-year college is preferred. Preference for mechanical, biomedical, or materials science.
  • Minimum 1-3 years of experience with a comprehensive knowledge of Medical Device regulations including FDA 21 CFR 820 and other applicable international standards with hands on experience in working within a quality systems under regulatory requirements including a background in device design, testing, and FDA clearance.
  • ASQ CQE and CQA Certifications or related quality/regulatory certification a plus.

Skills, Abilities, Competencies Required:
  • Excellent written and verbal communication skills
  • Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail
  • Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness
  • Strong organizational, analytical, and time-management skills
  • Able to self-motivate and work both independently and as part of a team
  • Strong computer skills
  • Good influencing skills, project management skills, and ability to work well independently and in a team setting.
  • Excellent organizational skills, interpersonal skills and verbal and written communication skills with the ability to interface with executive management, other functions within the company, and consultants and vendors outside the company.
  • Ability to exercise sound judgment and analyze and solve problems.
  • Ability to prioritize, plan and evaluate deliverables to meet established goals.
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint).
  • Ability to travel as needed (≤ 10% of the time).

restor3d is an Equal Opportunity Employer
 

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