Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapy for Type 1 diabetes, is seeking an experienced Quality Assurance Engineer to join its growing team. The qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take action, and have excellent written and verbal communication skills. The qualified candidate will provide quality assurance support for design and development, quality systems and compliance activities working cross-functionally with R&D, Manufacturing, QC and QA. The Quality Assurance Engineer will have a strong background, experience and/or understanding in Design Controls, Risk Management, Quality Systems, GMP Manufacturing and Combination Medical Devices. The position is a full-time role and will be based in Providence, RI.
- Provides quality assurance support in design and development activities of medical device products and facilitates the application of design controls and risk management.
- Support Design History File establishment, creation, approval and maintenance.
- Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to applicable design control regulations (21 CFR 820) and company policies and procedures.
- Review and approve design documentation including, but not limited to verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents (design and process).
- Support risk management activities including planning, design and clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
- Manage risk management file throughout product development cycle.
- Review new and modified product designs for quality characteristics, including manufacturability, testability, reliability, biocompatibility, sterility and conformance to product requirements.
- Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
- Provide leadership in all areas of the Quality System, including, but not limited to Root Cause Analysis, CAPA, Nonconforming Material Investigations and Reporting, Deviations, Change Control, Supplier Qualifications, and Audit support functions (internal and external).
- Provide leadership in the understanding and communication of medical device regulations to other disciplines.
- Know and follow applicable FDA regulations and policies that apply to one’s job, and maintain the highest level of professionalism, ethics and compliance at all times.
- BS in Engineering, or related technical or scientific discipline
- Minimum of 5-7 years industry experience working in medical or implantable biomedical devices
- Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management.
- Demonstrated knowledge of quality engineering, GMPs, QSR (21 CFR 820), Change Control, Supplier Quality, QC inspection, Design Control and Risk Management.
- Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it related to technical situations.
- Strong written and verbal communication skills are required, as is the ability to effectively. communicate with cross-functional teams and program managers.
- Highly detail oriented with strong organization and prioritization skills.
- Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.)
- Authorized to legally work in US on a continuous basis
- ASQ certifications (Certified Quality Engineer, Certified Quality Auditor, Six Sigma)
- Working knowledge of ISO 13485, ISO 14971 and combination product standards
- Practical knowledge and experience with statistical methods, including sampling size justification using Minitab or other statistical software
- Development and/or manufacturing experience
- Blueprint literacy including GD&T
- Familiarity with molding and assembly methodologies
Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.