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Quality Assurance Engineer

Employer
Fractyl Health
Location
Lexington, Massachusetts
Start date
Sep 9, 2021

View more

Discipline
Engineering, Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown

Position Summary

The Quality Assurance Engineer provides technical guidance and support for process validation, inspection, and quality system activities to ensure conformance to established specifications. S/he serves as a liaison between the company and various suppliers and manufacturing partners. The Engineer also facilitates the optimization and continuous improvement of internal operations to meet group and company objectives.

Primary Responsibilities

  • Implement and validate new production processes and test methods in Manufacturing during design transfer from Product Development.
  • Implement and validate new production and inspection equipment.
  • Write, implement, train, and improve inspection methods and forms.
  • Research improvements to manufacturing yields, data collection, test results, and record integrity.
  • Contribute to process design and inspection for new products during the development phase.
  • Develop and improve standardized documentation, including SOP’s, training, inspection, validation of equipment, and reports.
  • Provide accurate and timely project reporting to internal and external stakeholders.
  • Identify and resolve process and quality-related problems for assigned manufacturing processes.
  • Optimize current processes and identify emerging technologies for future implementation.
  • Execute corrective actions to solve problems and non-conformances based on root cause analysis.
  • Oversee manufacturing deviations to ensure proper containment and timely execution.
  • Provide support for acceptance, packaging, shipping, and export activities.
  • Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
  • Bring a “can do” spirit to work and deliver on other responsibilities as assigned.

Education or Certification Requirements

  • Bachelor’s Degree in a technical discipline.

Professional Work Experience

  • 1-3 years of Quality Engineering experience with medical devices
  • Must have experience with
  1. FDA Quality System Regulation (QSR).
  2. ISO 13485 and ISO 14971
  • Experience in biotech, pharmaceutical and/or medical device industries preferred.
  • Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).

Qualifications and Skills

  • Experience in facilitating design transfer
  • Experience in process and test method validations
  • Detail-oriented with solid analytical skills
  • Working knowledge of statistical techniques for data analysis, Minitab experience desirable
  • Solid computer skills essential, including PLM/ERP/CRM, Microsoft Office Suite, Adobe, SalesForce, SolidWorks, QC-CALC, etc.
  • Certification in QAE, Auditing, or Six Sigma is a plus.

Other ssentials and Key Success Factors:

  • Successful track record of working in high-growth and dynamic organizations
  • Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
  • Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
  • Evidence of "hands-on" experience and expertise
  • Proven and successful track record as a team-player and collaborator in small working environments
  • Highly organized and detail oriented with a passion to deliver quality results
  • Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
  • Highest levels of professionalism, confidence, personal values and ethical standards

Travel

  • This position requires up to 25% travel.

The description and requirements outlined above are general; additional requirements may apply.

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