Nanobiosym, Inc. Compliance Engineer in Cambridge, Massachusetts
21-Jul-2021 to 19-Sep-2021 (EST)
Cambridge, MA, USA
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Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine.
The Compliance Engineer is responsible for the organization and the coordination of processes pertaining to regulatory compliance and quality systems to ensure regulatory requirements for compliance.
The Compliance Engineer will work with cross functional team to update the existing CE tech files to ensure compliance with GMP and ISO requirements.
Individual with be responsible for Nanobiosym's QMS process and manage the system and drive compliance with the rest of the organization.
Work with Quality and Product Design Owners to ensure periodic review of risk management files per internal SOPs and ensure compliance to the product development process.
Will be responsible for Quality Systems metrics reporting to ensure compliance with defined procedures. Develop and help implement new metrics related to performance across all aspects of systems and processes.
Under general supervision establish and maintain quality system and compliance program, procedures and controls to ensure that the performance and quality of product conforms to the established processes and procedures.
Will work with product mfg engineering, product development engineering and research & development to review and ensure adherence to established procedures.
Bachelor's degree is required in Plastics Engineering, or Injection molding equivalent technical degree
A minimum of 5 years working in a medical device industry with working knowledge of design controls and product development is required.
Working knowledge of 21 CFR Part 820, QSR, ISO 13485, and MDD/IVDD requirements is required.
Ability to create documents and modify documents according to ISO 13485 standards
Ability to interpret and apply regulatory requirements and industry best practices is required.
Prior experience working with Hazard Analysis and Risk Management is required.
The successful candidate must be a critical thinker, detailed oriented, while overseeing multiple tasks for several projects or base business deliverables.
Excellent communication skills, both written and verbal are required.
Prior experience with Recalls/Field Action management activities is preferred,
Experience and knowledge of CAPA processes is desired.
Proficiency with computer applications (e.g., PowerPoint, Word, Excel, Visio) is required. Strong Excel skills are preferred.
You are passionate about new product development, healthcare, and mobile technology
You are methodical, detail oriented, well organized and effective at time management
You are a self-starter
You have good interpersonal, verbal communication, and documentation skills
You can function well in a challenging and fast-paced environment
You are enthusiastic and positive, with strong skills in the areas of dependability, flexibility, and maturity