Work Flexibility: Hybrid
This role will establish technical expertise for the Product security QMS in collaboration with Design Quality Digital group for Stryker T&E digital product
portfolios (Trauma, Foot & Ankle, Upper Extremities). The position requires a strong partnership with product
Development teams to ensure time-to-market, customer requirements, and technology objectives are met while ensuring compliance with global quality and regulatory requirements related to Product security. Will support the process owner – Product Security in establishing, implementing, and maintaining Global Regulatory and Quality processes and documents supporting our Global QMS and the divisional QMS.
What will you do:
Primary Responsibilities
Assist in the facilitation of internal and third-party audits as needed.
Should be capable of interpreting industry standards and government regulations to drive the implementation of world-class processes that may provide resources and/or help to remove obstacles to team accomplishments.
Should have Design Controls expertise for product development projects from inception through successful Design
Should have a basic understanding of product security & Risk Management strategies.
Recommend efficiency and process improvements to product security capabilities and functions.
Collaborate with product teams to assess security risks. Able to clearly convey design control and Product Security-related issues to stakeholders.
Creating Gap assessment between different processes and fulfilling the Gaps
Communicate the security gaps to leadership and propose mitigation solutions.
What You Need:
Knowledge/competence
5-8 years. Basic level Expertise in applying security control frameworks, security risk assessments, and scoring the severity of security threats and vulnerabilities.
Effective verbal and written communicator and consensus-builder
Demonstrated technical problem-solving skills.Strong QMS and SDLC (software development life cycle) understanding.
Basic Understanding of the vulnerability management life cycle. Experience of working in a regulated medical organization.
Good to have
ISO 13485 standard .Experience in New Product Development for Software and/or Systems preferred
FDA Cybersecurity guidance (including FD&C 524B and eSTAR updates)
Hands on experience in using Agile methodology.
Understands security risk management processes preferably in the healthcare or medical device industry
Travel Percentage: None
