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
- FDA Quality System Regulation (QSR).
- 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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