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Cybersecurity/ Quality systems/ Compliance Analyst - Saint Paul, United States - DivIHN Integration Inc
Description
DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at
to learn more and view our open positions.Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Divya at
Sivanesan at
Title: Cybersecurity/ Quality systems/ Compliance Analyst
Location: St. Paul, MN Or Waukegan, IL/ Abbott Park, IL/ Chicago, IL
Duration: 7 Months
Description
This is a non-exempt role.
Product Cybersecurity is seeking an energetic team player with strong initiative, problem solving, and organizational skills. The individual can also handle multiple assignments simultaneously while meeting assigned deadlines and service levels. Effective communication and the ability to maintain a positive rapport with internal customers and partners is a must.
6 years of Medical Device industry work experience in cybersecurity, information security or related role or equivalent skill/experience.
Expertise in maturity assessment frameworks, Medical Device FDA guidance, related global regulation and industry standards including: NIST, FDA Pre and post market guidance, ISO, IMDRF.
Broader expertise in [Global] Quality System regulation desired (e.g., 21 CFR Part 807, 814, 820, 11).
Ability to manage, administer, and support maturity assessment completion, capture results, remediation, and reporting.
Advanced technical skill in Microsoft products, such as Forms and Excel or advanced programming skills in Python or other languages or the ability to quickly learn appropriate technologies.
Ability to design and develop reports utilizing a tool like Power BI.
BA/BS degree in MIS, Computer Science, Cybersecurity, Information Assurance, or related field.
Duties:
Define the Product Cybersecurity Maturity Assessment in collaboration with IT and division cybersecurity leaders and subject matter experts based on a or multiple selected industry standard(s)/framework(s).
Develop a software interface/data capture for the administration of the assessments utilizing an appropriate platform.
Facilitate the completion of the maturity assessments in collaboration with IT and division cybersecurity leaders.
Capture results and develop/distribute appropriate reports for all levels of the organization including executive/c-suite.
Capture and provide input to remediation in collaboration with various areas such as control monitoring.
Develop and complete a project charter for the remediation of product cybersecurity tools and systems to ensure compliance with quality system requirements.
Partner with Client Quality and Regulatory and other functions, as appropriate, to ensure Product Cybersecurity policy is maintained.
Support other product cybersecurity leaders, as appropriate, to advise, review, and solidify process and procedures to meet security and quality system requirements.
Automate manual tasks, time permitting.
Contribute to the development of a risk-based cyber security program which meets regulatory requirements and aligns with industry leading information security practices.
Perform threat identification and mitigation activities using industry leading security controls and tools sets.
Support the advancement of the Company s cyber threat and vulnerability management program to ensure consistent identification, analysis, response, and monitoring of cyber security threats, events, and vulnerabilities.
Assess threats to the business and deploy countermeasures for those threats.
Guide business units, application development teams, and third-party vendors to achieve program requirements while enabling the business.
Apply technical knowledge to protect the Company against cyber threats (e.g., knowledge of firewalls, intrusion detection and prevention systems, data loss prevention solutions, endpoint protections, log aggregation technology and other leading-edge security technologies).
Participate in cross-team coordination to achieve defined security goals as well as meet technical requirements in support of detailed implementation plans for security projects.
Contribute subject matter expertise on security projects to ensure the timely, on budget, and effective implementation of cyber security improvements that are operationally supported with validation methods in place to measure effectiveness.
Perform assessment of cyber security incidents to identify the root cause, respond, and recover the environment.
Support management in the development of strategies, policy and standards to protect company information and technology assets.
Quality systems/compliance - Medical device with cyber security guidance is required
understand the product security assessment/Maturity assessment is required
understanding the ISO standards.
Technical skills: Python or Java
Top Skills:
Knowledge or assesment of cybersecurity ISO standards
Maturity assessment frameworks, Medical Device FDA guidance
Interview: 2 Rounds
1st Video Interview.
2nd Inperson interview
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Cybersecurity/ Quality systems/ Compliance Analyst professionals in Saint Paul
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Jane Biessener
Customer Support