Software Compliance Engineer
Essential Functions and Responsibilities:
* Collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensure that business needs are met
* Application of ISO 13485, QSR 820, and ISO 14971 standards, especially 21 CFR 30 design controls to software development projects.
* Implementation of 21 CFR Part 11 Compliance, Data Privacy Software controls
* Participate in the completion and maintenance of hazard analysis, FMECA’s and Cybersecurity risk assessments
* Perform labeling verification and generate labeling verification reports
* Complete Document Change Request Reviews in a timely and objective manner
* Work with design engineering in the completion of software/system requirements
* Work with design engineering in the completion of product verification and validation
* Participate in the development process to support quality disciplines, decisions, and practices
* Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
* Identify and implement effective process control systems to support the development, qualification, and on- going manufacturing of products to meet or exceed internal and external requirements
* Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
* Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
* Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
* Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements
* Supports business during regulatory and supplier audits
* Complies with S.
Food and Drug Administration (FDA) regulations, Health Canada regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
* Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
* Performs other related duties and responsibilities, on occasion, as assigned
Requirements
Knowledge, Skills and Abilities:
* Excellent written and verbal communication and interpersonal skills
* Knowledge of medical device design controls requirements from FDA, ISO and other global regulatory
* Knowledge on AAMIISO TIR80002-22017 and TIR362007
* Advanced computer skills, including statistical/data analysis and report writing skills
* Ability to work within a team and as an individual contributor in a fast-paced, changing environment
* Ability to leverage and/or engage others to accomplish projects
* Strong verbal and written communications ...
- Rate: Not Specified
- Location: Colchester, US-VT
- Type: Permanent
- Industry: IT
- Recruiter: Data Innovations
- Contact: Not Specified
- Email: to view click here
- Reference: SOFTW017984
- Posted: 2025-03-27 07:37:02 -
- View all Jobs from Data Innovations
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