Labeling Engineer
GForce Life SciencesSunnyvale, CA, United Statesjob_description.job_card.variable_days_ago
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job_description.job_card.job_descriptionManage and qualify all lab test equipment Perform a broad variety of tasks in support of label verification and process design established by departmental goals Deep understanding of design controls processes related to verification and validation Perform equipment validation as required (IQ / OQ / PQ) Ensure successful, on-time completion of department projects; communicate constraints to direct management when successful project completion is at risk Own label verification deliverables for assigned projects as the Subject Matter Expert (SME) Actively contribute to core team meetings by providing insights, and updates on project deliverables, ensuring alignment with overall project goals Collaborate closely with Packaging and Test Engineering teams to drive seamless integration, troubleshoot issues, and ensure compliance with quality and performance standards Working knowledge of tools for label development such as Robar, Prisym360, Bartender, PLM (Agile), issue tracking (Jira), and software testing (Qtest) is preferred. Experience with Polarion or other equivalent requirements tracing software is a plus Experience working in a regulated industry is preferred. Strong understanding of medical device standards including ISO, FDA, GDP, and GMP guidelines is preferred. Prior experience with labeling equipment, such as thermal transfer printers, Form-Fill-Seal (FFS) systems, and UV laser markers is a plus Comfortable making risk-based decisions, interpreting regulations, and explaining and justifying strategies based on quality systems Able to learn and apply established procedures in a reliable and consistent manner Strong leadership, negotiation, interpersonal, communication, and facilitation skills Ability to lead and deliver in a matrix organization environment Excellent written and verbal communication skills with the ability to work effectively across departments and influence stakeholders Strong problem-solving skills and ability to be self-managed in a fast-paced environment utilizing agile / sprint methodologies Proficient with MS Office applications, including Word, Excel, Outlook, and Teams Travel ~10% Intl / domestic
Labeling Engineer - Design Verification
6 month contract
Must be able to work on a W2
On-site in Sunnyvale, CA
Roles and responsibilities
- Generate and take ownership of test protocol design, strategy, test execution, trace matrix, test report, artifacts, and related activities
- Perform all upstream and downstream requirements tracing using tools such as Polarion or equivalent
- Develop and execute test protocols for product labels
- Clearly document test results and observations in test reports
- Review and recommend improvements to test methods, leverage / incorporate industry best practices, collaborate with cross-functional partners and adhere to quality standards
- Identify and present problems that arise during feasibility and design verification testing, and escalate new or persistent failure modes to appropriate engineering teams
- Proactively engage with engineering teams on failure investigation and root cause analysis
- Passionate about achieving first-time-right results
Other responsibilities :
Technical skills
Other skills and abilities
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Engineer • Sunnyvale, CA, United States
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