BioTelemetry, Inc. Quality Engineer/Technical Writer in Concord, Massachusetts
BioTel Care, a division of BioTelemetry, Inc. is seeking a Quality Engineer with Technical Writing expertise for our Concord, MA location. Independently author and review quality system documents (e.g., Software Requirements Specifications, Verification and Validation Protocols and Reports) and ensure that they are correct, valid, and documented correctly for compliance with associated standards, business requirements, and/ or regulatory body requirements.
Explain scientific and technical ideas in a clear language.
Meet with developers, engineers, and business representatives to understand technical requirements and specifications.
Study drawings, specifications, mockups, and product samples.
Create user documentation for a variety of material, including how-to guides and instruction manuals.
Ensure technical verbiage is easy to understand by the layperson for all manuals.
Prepare charts, graphs, or forms to go along with rough drafts.
Ensure fields flow in the correct sequence.
Write clear and concise policies and procedures.
Create table of contents and cite sources, maintain all documentation in such a manner as to meet all standards, business, and regulatory requirements.
Submit copies to managers for feedback.
Adjust copy as necessary and proofread for grammar and spelling.
Adhere to document development life cycle(s).
Release the document following final approval to the electronic document management system.
Provide updates and different editions as necessary.
Participate in inspections by FDA and other regulatory bodies and respond to observations
Perform internal and supplier quality audits as per 21 CFR 820 and ISO 13485:2003. Ensure that all purchased or otherwise received product and services conform to specified requirements.
Draft and review Product Change Notices and Deviations to ensure that they are correct, valid, and documented correctly for compliance to FDA and other regulatory bodies.
Maintain and review DHFs, DMRs, DHRs, and Technical Files for accuracy and compliance to internal and FDA and EU Notified Body requirements.
Develop and maintain Quality systems and procedures, inspection plans, process validation and equipment qualification procedures, in a hands-on manner.
Bachelor’s Degree in Engineering
Experience with software driven electromechanical devices would be a strong plus
Experience in Blood Glucose Meters would be a plus
Knowledge of FDA QSR, EU In Vitro Diagnostic Device Directive, and ISO 13485:2016 requirements would be a plus.
Knowledge of Design Controls, DHF, DMR and cGMP would be a plus
Knowledge of Process Validations and statistical analysis techniques (confidence and reliability, process capability, etc.) would be a plus
Strong communication skills – verbal and written
Displays a positive attitude
Demonstrates flexibility in day-to-day work.
Sets high standards of performance for oneself.
Establishes harmonious working relationships with team members.
Appreciates each team member’s contributions and values.
Values internal and external clients and responds to their needs as they arise.
Establishes effectives working relationships with clients.
Follows established communication guidelines.
Uses good judgment in what and how to communication with clients.
Understands the professional development process and becomes actively involved by setting challenging goals and meeting them through continuous learning.
Seeks input from mentors and supervisors.
Actively applies feedback received to day-to-day work and strives to improve performance.
Accurately completes and submits time and expense reports.
Accurately completes and submits status reports in a timely manner.
Complies with all of our policies and procedures.
BioTelemetry is an Equal Opportunity Employer
External Company Name: CardioNet
External Company URL: http://www.cardionet.com/
Street: 150 Baker Ave.