Posted in Other 30+ days ago.
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Type: Full Time
Location: Concord, Massachusetts
Quality Engineer/Technical Writer
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.
POSITION SUMMARY /KEY RESPONSIBILITIES
* 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
BioTelemetry is an equal opportunity employer who strictly prohibits discrimination against any employee or applicant for employment because of the individual s race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, veteran s status, or any other characteristic protected by law. Affirmative action will be taken to ensure that all employment decisions, including but not limited to those involving recruitment, hiring, promotion, training, compensation, benefits, transfer, discipline, and discharge, are free from unlawful discrimination.