Sr Quality Engineer
Location Marlborough, MA, US
Department Name 564110 THINPREP-R&D-ENGINEERING-QUALITY
Shift Information First Shift
Summary of Duties and Responsibilities
The Sr. Quality Engineer provides medical device Quality Assurance technical expertise by participating in the day-to-day operation of the Department as it relates to the design and manufacture of medical devices.
· Acts as the Design Assurance representative to new product development teams:
o Provides input on Product Requirements documentation
o Reviews/approves specifications, drawings, manufacturing procedures
o Aids in the development of Inspection Procedures and Test Methods
o Reviews/approves design verification and validation documentation
o Drives Risk Management activities
o Develops Product Quality Plans
o Interfaces with Supplier Quality on new supplier selection, qualification and supplier agreements
· Provides Quality Engineering support to existing products:
o Coordinates risk assessments and updates Risk Management documentation as required
o Assists Quality at external manufacturing sites on root cause investigations and corrective actions.
o Supports Quality Control with technical input on inspection documentation and with the Material Review Board (MRB)
o Reviews product-related change orders, engineering studies and sustaining engineering projects to assure high quality products and adherence to Quality System requirements.
o Interfaces with Post-Market Quality to review and act upon trended data from complaint investigations and manufacturing metrics.
· Provides Quality System support to assure compliance with current Medical Device Quality System Regulation and Medical Device Directive requirements:
o Assists QA Manager in identifying and implementing quality system improvements, specifically for elements related to product quality.
o Performs internal audits of the Quality System and participates in external quality audits.
· May include other duties as defined by the Quality Assurance Manager.
Qualifications
Very good working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485 and MDD requirements.
· Computer literate: able to use word processing, spreadsheet programs, databases.
· Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
· Excellent writing skills with ability to write quality assurance reports and detailed procedures.
· Good presentation skills.
· Good interpersonal skills to interact with all levels of the company.
Education
* Bachelor's degree (BA or BS) in a technical discipline
Experience
5+ years related experience in an FDA regulated industry or equivalent combination of education and experience.
Specialized Knowledge
· Certified Quality Engineer desirable.
· Experience with sterilization and cleanroom processes preferred.
