Quality System Engineer
Quality System Engineer- Boston, MA
Our Boston-based Medical Device client is developing scientific products that allow physicians to make evidence-based decisions. They are currently growing and looking to hire a Quality System Engineer whowould have the following responsibilities:
- Responsible for activities required to ensure compliance of companies' Quality Management Systems (QMS), specifically regarding Customer Complaints.
- Support other QMS functions such as Management Review, CAPAs, NMRs, Risk Review, etc.
- Gather information necessary to conduct thorough and accurate complaint investigations, including additional event information/descriptions, Good Faith Efforts (GFE's), and patient status information.
- Product status and return authorizations.
- Execution and coordination of activities associated with the company complaints process, including complaint administration and record management, investigations, reporting, as well as metrics and trending.
- Coordinate with the cross-functional team where necessary
- Perform risk assessments utilizing released product risk documentation such as PFMEAs and UFMEAs.
- Use a data-driven approach to the decision-making process, including evaluation of product performance.
- Make reportability decisions promptly to ensure compliance with FDA regulations.
- Write customer letters to inform users about Best Practices or Instructions for Use as needed.
- Support field actions and other post-market surveillance activities when required.
- Support the company business as a subject matter expert concerning investigation tools and techniques, statistical analysis, as well as proper documentation practices.
- Identify opportunities for improvement within the Quality System to ensure compliance and efficiency.
- Support work on quality plans, quality processes, and special projects, as required.
- Bachelors in Engineering, Biomedical Science, or technical degree preferred
- 2-3 years of relevant experience in the medical device industry.
- Knowledge of Quality System Standards and regulations including ISO 9001, ISO 13485, and QSR
- Experience in operational quality function within a device manufacturing environment strongly preferred
- Strong written/verbal communication and project management skills
- Strong analytical, deductive reasoning and listening skills
- Experience in the creation and documentation of procedures and processes
- Must be able to communicate precisely and accurately to all levels of the organization
- Proficiency with Microsoft Office – Word, Excel, PowerPoint, and Access experience required
If interested, please contact Earl Callender at email@example.com