58 applicants

Company

Original Job Post

Advanced Sterilization Products · 4 days ago

Quality Systems IT Analyst

United States

Full-time

Remote

Mid Level

$80K/yr - $148K/yr

3+ years exp

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Responsibilities

Examine current QMS & PLM processes and identify opportunities to improve efficiency and compliance through system controls and automation.

Collaborate with stakeholders to Analyze, develop, and communicate business and technical requirements for QMS & PLM systems.

Participate in and lead kaizens to collaboratively deep dive into QMS & PLM performance.

Identify and oversee the implementation of continuous improvement opportunities in the respective IT Systems.

Train end-users on new features and enhancements. Create communication and job aids to support adoption of new functionality.

Establish strategic roadmap for QMS/PLM solutions aligned with ASP strategic initiatives

Ensure alignment with regulatory standards (e.g., ISO 13485, 21CFR820, EU MDR, MDSAP).

Collaborate with development and support teams to design business solutions that leverage the simplest technical solution and intelligent architecture to minimize future debt and maximize re-usable components.

Establish user stories, business cases, and acceptance criteria to translate and break down desired outcomes into functional layers a developer can bring to life.

Establish development priorities for monthly sprints, perform technical and functional reviews of developed solutions, and oversee user acceptance testing to ensure solutions meet user needs and are validated for on-time delivery.

Develop and maintain test cases that ensure desired functionality is maintained and future enhancements don’t cause regression issues.

Integrate data from various sources into QMS and PLM systems.

Generate regular management reports and dashboards on quality metrics.

Support Quality, Regulatory, R&D, and Supply Chain staff in monitoring and improving products and processes.

Responsible for communicating business-related issues or opportunities to the next management level

Performs other duties assigned as needed

Qualification

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Medical Device IndustryQuality SystemsProduct Lifecycle ManagementQuality/PLM System DesignValidationChange ManagementMedical Device Quality System RegulationsISO 1348521CFR820EU MDRMDSAPProblem SolvingCommunicationAnalytical SkillsEnthusiasticHighly MotivatedQuick LearningCreative Problem SolvingProactiveAdaptableCuriousPropel SoftwareSalesforceAtlassian JIRAAtlassian ConfluenceProject ManagementOrganizedProblem-Solving

Required

Bachelor’s Degree

At least 3 years’ experience in the Medical Device industry or medical field with specific experience in establishing and driving continuous improvement of quality systems and/or product lifecycle management applications in a regulated environment.

Experience with quality/PLM system design, validation, training, and change management.

Knowledgeable and experienced with understanding medical device quality system regulations and standards (e.g. ISO 13485, 21CFR820, EU MDR, MDSAP).

Strong verbal and written communication skills. Ability to effectively communicate and translate highly technical information in a professional manner at all levels.

Strong analytical skills to identify issues and troubleshoot problems.

Enthusiastic, highly motivated, quick learning, creative problem solving, proactive, adaptable, and curious.