Quality Engineer - Product Quality

At Lumicell, we’ll give you the opportunity to harness all that’s within you by working in a mission driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery.  We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer. Every two minutes, a person is diagnosed. Our founder, David Lee lost his wife to breast cancer due to cancer being left behind during surgery. You will be a part of something groundbreaking as we transition from clinical development to our commercial launch.  

Position Summary: 

Lumicell is seeking a highly-motivated Quality Engineer to work in a dynamic, fast-paced start-up environment. This is an excellent opportunity to join the organization as it scales for commercialization.

The Quality Engineer shall provide quality support and guidance to the organization through active involvement in equipment/test metrology, statistical analysis, process/product verification and validation, risk management, supplier qualification and management, process/product development, and document control.

• This role requires the candidate to be onsite in Newton, MA; occasional remote work is acceptable. 

• Occasional travel is required for this position including internal meetings, supplier and contractor manufacturer site visits, conference and/or training events.

 Responsibilities: 

• Provide support to manufacturing, project, and product development activities and integrate quality considerations throughout the product life cycle
• Facilitate the following processes in accordance with internal procedures:
  • Design Changes and Design Transfer
  • Nonconforming Materials Reporting
  • Deviations
  • Supplier Qualifications
  • Supplier Corrective Actions
• Perform Internal Quality Audits as required
• Support 3rd-Party audits and Regulatory Inspections
• Participate in planning meetings with 1st tier and 2nd tier suppliers to provide quality support for ongoing manufacturing activities and issues
• Adhere to all company policies and act as a role model in the adherence to policies application/interpretation and customer expectations
• Create, develop and analyze statistical data to assure supplier and product performance is to expected quality levels and to identify opportunities for improvements within the operation
• Perform Document Control duties as required including drafting, revision and release of SOPs and procedures required for QMS support
• Additional duties as required

Experience / Requirements 

• Bachelor of Science in Engineering or Science or a minimum of 5 years in a Quality Assurance position required, CQE (Certified Quality Engineer), Six Sigma Green Belt, is a plus
• Solid understanding of quality management systems related to ISO 13485 and 21CFR Part 820. Thorough understanding of document control and record management per ISO 13485/QSR is required
• Must have experience in the areas of design control, risk management, auditing both supplier and internal, and manufacturing under ISO 13485/QSR (21 CFR Part 820), CBA (Certified Biomedical Auditor) a plus
• Experience with capital equipment and sterilized disposable single use product
• IEC 60601 series testing experience a plus
• Must possess computer application skills, MS Office, PLM, ERP, statistical software tools a plus
• Strong facilitation and communication (written and verbal) skills are required
• Verification and Validation experience for new product development and process control preferred
• Strong organizational skills are required, ability to work independently in a fast paced rapidly changing environment

Lumicell is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.