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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in supporting Integrated Management Systems and compliance assessments, with a strong focus on quality assurance and regulatory requirements. Proficient in agile software development principles and capable of delivering effective training and collaboration across teams.
Highest-signal resume keywords
ISO 13485 Compliance21 CFR Part 820 & Part 11 KnowledgeAgile Software Development SupportKPI Monitoring and ReportingInternal and External Audit Participation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Integrated Management SystemsCompliance AssessmentsTest Planning and ExecutionNon-Conformities TrackingCAPA ManagementQuality AssuranceRegulatory RequirementsContinuous Improvement InitiativesInformation Security KnowledgeSoftware Tools for Compliance Management
Soft Skills
Proactive InitiativeSelf-DrivenAttention to DetailEffective CommunicationPresentation Skills
Industry Keywords
Biomedical EngineeringProduct Life CycleQuality Management SystemsEU MDRIVDRAgile PrinciplesISO 27001
About the role
Key responsibilities & impact- Support implementation of Integrated Management Systems SOPs
- Support all phases of the product life cycle, including requirements development/review/approval, test planning, test execution, test reporting and assessment
- Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
- Participate in assigned continuous improvement initiatives
- Conduct activities related to internal and external audits as assigned
- Track Non-Conformities and CAPAs to closure cross organization
- Timely monitor and report on KPIs
- Provide quality related trainings
- Collaborate across teams to deliver the responsibilities
Requirements
What you’ll need- BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent degree
- 5+ years of relevant industry experience with demonstrated achievements in the areas of responsibilities mentioned above.
- Sound knowledge of Industry standards: (e.g., ISO 13485,) and good understanding of Regulatory requirements: 21 CFR Part 820 & Part 11, EU MDR or IVDR, Annex 11
- Good understanding of agile software development support ways of implementing agile principles in a regulated environment.
- Fluency in English
- Knowledge & experience of managing compliance using software tools
- Quick learner, self-driven & self-organizing and able to work independently
- Proactive and with ability to take initiative
- Precise, accurate, with an eye on details and can to attitude
- Very good oral, written communication, and presentation skills
- Good understanding of information security domain (ISO 27001) is a plus
Benefits
Comp & perks- Flexible Work & Time Off - Embrace hybrid work models and enjoy the freedom of unlimited paid time off to support work-life balance.
- Health & Well-being - Access comprehensive group medical and life insurance coverage, along with a 24/7 Employee Assistance Program (EAP) for mental health and wellness support.
- Growth & Learning - Fuel your professional journey with continuous learning and development programs designed to help you upskill and grow.
- Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable.
- & Many More...