Quality System Engineer

1 month ago

Bedford, United States InfraReDx Full time

Responsibilities

• Supports the complaint handling process for the organization. Responsible for activities required to ensure compliance of Infraredx Quality Management Systems (QMS), specifically regarding Customer Complaints. Additional responsibilities include supporting other QMS functions such as Management Review, CAPAs, NMRs, Risk Review, etc.

• Execution and coordination of activities associated with Infraredx complaints process, including complaint administration and record management, investigations, reporting, as well as metrics and trending.

• Compose Monthly Complaints Meeting materials and present to Senior Leadership team.

• Coordinate with cross-functional team where necessary, understanding how to best leverage resources and functions within each business unit throughout the organization in order to succeed.

• Perform risk assessments utilizing released product risk documentation such as PFMEAs and UFMEAs. Ability to identify gaps in current documentation while providing constructive feedback necessary for modifications.

• Use data driven approach throughout all aspects of role and decision making processes, including evaluation of product performance. Approach shall remain consistent regardless of stated objectives and/or goals.

• Gather information from all available sources to make timely reporting decisions, including ability to interpret clinical data and customer feedback. Demonstrated understanding of system functionality, allowing engineer to work in independent fashion, utilizing SMEs only when necessary.

• Write customer letters to inform users about Best Practices or Instructions for Use as needed.

• Responsible for supporting field actions and other post market surveillance activities when required.

• Support the Infraredx business as a subject matter expert concerning investigation tools and techniques, statistical analysis, as well as good documentation practices.

• Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation. Related activities may include standardization of investigation techniques utilized in Complaint investigation process including product evaluation and testing.

• Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action.

• Ability to mentor and lead less experienced engineers in all aspects of complaint administration process, including providing feedback on complaints handling process and day-to-day activities.

• Support work on quality plans, quality processes, and special projects, as required.


Minimum Requirements

• Bachelors in Engineering, Biomedical Science, or technical degree preferred, with 2-5 years of relevant experience in 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

• Experience participating in internal and external audits, preferably serving as qualified internal auditor

• 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

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