Semma Therapeutics

Job Title: Quality Control Engineer, Device Manufacturing

Job Number: 21395

Location: Providence, RI

Job Description

Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking a Quality Engineer to join its growing team. The full-time role will support device manufacturing activities of Semma’s cell encapsulation device platforms. The Quality Engineer will be responsible for quality control and compliance in manufacturing. The successful candidate will have a good understanding of the medical device field, GMP manufacturing, quality control, metrology, knowledge of statistics, risk management, test method planning and process validations. The position is in Providence, RI and will report to the Director of Device Manufacturing.

Responsibilities

  • Develop and implement quality plans, test methods and metrology for the device
  • Lead development of fixtures, OGP Flash 200 programs and acceptance criteria
  • Lead review of quality records and set up DMRs and DHRS
  • Conduct process evaluations and validations utilizing tools such as SPC, DOE, PFMEA, MSA and capability studies
  • Identify, evaluate and implement purchase specifications and supplier controls
  • Develop and lead projects to improve efficiency, quality and reduce costs
  • Conduct root cause failure analysis and corrective action
  • Participate / lead risk management activities including FMEAs
  • Identify product failure modes and provide possible solutions through product quality and process improvements
  • Participate / lead verification and validation activities for design, process or products
  • Development and qualification of test methods for verifications and validations
  • Support design control and risk management activities

Required Skills

Required Qualifications:

  • BS in Engineering, or related discipline
  • Over 7-10 years industry experience working in medical or implantable biomedical devices
  • Demonstrated knowledge of quality engineering, medical device regulations, supplier quality control, design control and risk management.
  • Working knowledge of FDA and other applicable medical device and combination product standards
  • Ability to communicate effectively with a diverse range of scientists, physicians, engineers, regulatory specialists and business professionals
  • Demonstrated excellence in planning, executing, and project management
  • Authorized to legally work in US on a continuous basis

Preferred Qualifications:

  • ASQ certifications in ISO 13485 and 21CFR 820 Compliance of medical devices
  • Deep understanding of statistical analysis and six sigma methodology
  • Knowledge of Minitab and DOE software
  • Familiarity with molding and assembly methodologies
  • Experience operating under design control and GMP manufacturing
  • Ability to manage activities and quality control initiatives through timelines to meet corporate goals

 

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