Medical Device Designer & Contract Manufacturer of single use instruments and disposables

  • Locations in Rochester, NH & Tijuana, Mexico
  • +1 (603) 332-8900

Quality Engineer

Growing contract manufacturer for single use, disposable medical devices is looking for a dependable individual to join our team.  The Quality Engineer should be a self-driven team player who has strong organizational and communication skills.  This position reports to the Quality Assurance Manager.

Responsibilities include:

  • Monitoring and improvement of product quality.
  • Defect, scrap and rework prevention.
  • Continuous improvement of and adherence to Quality Management System.
  • Control, document, evaluate and disposition nonconforming materials.
  • Coordinate and monitor inspection activities
  • Investigate, document and communicate customer complaints.   Notify QM if event is reportable per Medical Device Vigilance Reporting standards and requirements
  • Supplier Quality evaluation, monitoring, and improvement.
  • Review and approve validation activities.
  • Support Design and Design Transfer activities as needed.
  • Sterilizations for both ETO and Gamma Radiation in accordance with the appropriate standards.
  • Ensure adequacy and compliance of Environmentally Controlled Areas.
  • Provide support for and perform Document Control activities as needed.
  • Coordinate and perform Corrective Action and Preventive Action activities as required.
  • Internal auditing as required.
  • Provide guidance on regulatory requirements.
  • Perform and/or prepare installation, operational, and performance qualification of equipment as needed.
  • Provide product specifications and task specific instructions for use by Assembly and Quality, personnel and when required specifying the type of inspection or measuring equipment to be utilized.
  • Conduct investigations for equipment failing calibration.
  • Complete, review and approve fixture files as necessary
  • Assist in maintaining traceability of products.
  • All other duties as assigned.

Required Skills, Knowledge and Expertise

  • Working knowledge of ISO13485, ISO 9001, FDA CFR Part 820, Medical Device Directives
  • Medical Device Directives and product – specific applicable standards
  • FDA Quality System Regulations
  • Canadian Medical Device Regulations
  • EtO sterilization
  • Gamma Sterilization
  • Statistics
  • Quality Management Tools
  • Problem Solving
  • Root Cause Analysis
  • Supplier Performance
  • Project Management
  • Advanced Product Quality Planning (APQP)
  • Proficient in Microsoft Office Software suite

Desirable Qualifications

  • Scientific education (biological sciences or other technical)/Quality Certifications (ASQ or other)/Quality/Regulatory experience in medical device manufacturing

 

 

 

 

 

Candidates can submit resumes to This email address is being protected from spambots. You need JavaScript enabled to view it..

Competitive benefits offered; however, Phase 2 Medical does not offer relocation packages.

Unsolicited, Non-Contracted Agencies not subject to “finder’s fee”.

       

Locations

Product Development & US Manufacturing

88 Airport Drive
Rochester, NH 03867

+1 (603) 332-8900


Mexico Manufacturing

Andador Vecinal No 14301
Tijuana, BC CP22330

+1 (664) 231-3844