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 ...