- Stryker (Fort Wayne, IN)
- …validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements. + Partner with cross-functional teams, including ... software lifecycle by implementing software industry best practices and regulatory standards ( FDA , TGA, EUMDR, IT). + Engage in design and development activities for… more
- Stryker (Portage, MI)
- …in the Medical Division. + Collaborate on software design, development, and validation strategies, ensuring alignment with Quality Management Systems compliance ... Security Risk Assessments and defect management, software testing and/or verification/ validation . **Preferred:** + Bachelor's degree in Computer Engineering,… more
- Integra LifeSciences (Braintree, MA)
- …**RESPONSIBILITIES** + Responsible for supporting the maintenance of the document control system during 1st shift. + Day-to-day management of resources, planning to ... and deadlines + This role ensures compliance within the document management system , document storage, retention, and document reconciliation + Serve as a document… more
- GE HealthCare (Waukesha, WI)
- …and products. This role requires deep expertise in Quality Management Systems (QMS), infrastructure modernization, and delivery of compliance-critical artifacts to ... standards. **Quality & Compliance Leadership** + Author and execute ** Validation Plans** , **Verification Plans** , and **Test Protocols**...and **Test Protocols** in accordance with ISO 13485 and FDA 21 CFR Part 820. + Conduct **Failure Modes… more
- Actalent (Minneapolis, MN)
- …degree in a relevant science or engineering discipline. + Experience in process validation , change control systems , and sample size determination. + Familiarity ... engineering support to US Operations to ensure compliance with FDA regulations. + Act as the first line support...control for products and processes. + Review and author validation documents and validate processes. + Initiate Change Requests… more
- Abbott (Alameda, CA)
- …**What you'll work on** + Lead software development, verification, and validation ; responsible for on-time delivery of high-quality embedded software biowearable ... approved design control procedures for software development in accordance with FDA guidelines. + Lead software development projects, providing mentoring and… more
- Katecho (Des Moines, IA)
- …the development, implementation, and continuous improvement of quality management systems , compliance with regulatory requirements, and coordination of internal ... + Quality Management: Oversee and maintain the company's Quality Management System (QMS), ensuring alignment with both internal and external standards, including… more
- Globus Medical, Inc. (West Carrollton, OH)
- …standards and procedures. Uphold the company's quality standards and testing systems to reflect efficiency, reliability and performance. Assist in the creation ... Functions:** + Reviews product and process changes for qualification and validation requirements, and assists in change implementations + Implements systems… more
- Teleflex (Mansfield, MA)
- …experience of working in the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems , strongly desired * Experience in ... and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes. Adhere safety, manufacturing and Quality procedures and… more
- Medtronic (North Haven, CT)
- … Validation and Verification Responsibilities** + Define and manage systems requirements to ensure clarity, completeness, and testability. Collaborate with the ... services, and solutions, is seeking a highly skilled and experienced Principal Systems Quality Engineer supporting the NPD surgical team. The ideal candidate will… more