Job Description: » 4-6 years of experience using FlexiCapture and FineReader
» Extensive experience in designing and creating OCR image templates
» Experience in Invoice Processing and Accounts Payable preferred
» Ability to develop Scripts as required from time to time
» Ability to work independently without much hand holding
Role: Senior Quality Engineer Location: St. Paul, MN - 55117 Duration: 10 Months
Skills Required » Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies.
» Detailed knowledge of FDA, GMP, and ISO 13485 Solid communication and interpersonal skills.
» Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
» Advanced computer skills, including statistical/data analysis and report writing skills.
» Prior medical device experience preferred.
» ASQ CQT, CQE, CQA certification preferred.
» Six Sigma, root cause analysis/problem solving training and experience preferred. - Experience working in a broader enterprise/cross-division business unit model preferred.
» Ability to work in a highly matrixed and geographically diverse business environment.
» Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
» Ability to leverage and/or engage others to accomplish projects.
» Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
» Multitasks, prioritizes, and meets deadlines in timely manner.
» Strong organizational and follow-up skills, as well as attention to detail.
» Ability to travel approximately 10%, including internationally.
» Ability to maintain regular and predictable attendance.
Education And Experience
» Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
» 5+ years technical experience.
Job Title: Supplier Quality Engineer Location: MA
Key Responsibilities: » Quality Standards: This role requires you to establish and maintain supplier quality standards, ensuring they align with industry regulations and the company's internal requirements. This could involve creating detailed specifications and inspection criteria and regularly updating them as needed.
» Supplier Performance: You will be monitoring key performance metrics for suppliers, including defect rates, on-time delivery, and overall quality improvements. This also involves reporting on these metrics to stakeholders within the organization.
» Root Cause Analysis: A significant part of this role is conducting root cause analyses for quality issues and non-conformances. You will need to work closely with suppliers to identify the underlying causes of these issues and drive corrective and preventive actions.
» Quality Improvement: As a consultant, you will lead initiatives to improve quality processes, working with suppliers to implement process changes and continuous improvement plans. This might involve introducing new quality control methods or collaborating on quality-focused projects.
» Regulatory Compliance: Given that this role is in the medical device industry, you need to ensure that suppliers comply with all relevant regulations and industry standards, including FDA QSRs, ISO13485, and others. This also involves staying updated with regulatory changes and advising suppliers accordingly.
» Risk Management: Identifying and mitigating risks related to supplier quality is critical. This could involve risk assessments, contingency planning, and addressing potential supply chain disruptions.
» Cross-functional Collaboration: The role requires close collaboration with other internal departments, such as procurement, engineering, manufacturing, and quality assurance. Effective communication and teamwork are essential.
» Documentation: Maintaining accurate and comprehensive records of all supplier quality activities, including audits and quality agreements, is part of the role's responsibilities.
Job Qualifications Educational Background: A bachelor's degree in an engineering discipline is required, providing a technical foundation for the role. Experience: The ideal candidate has 7-10+ years of experience in Supplier Quality within the medical device industry. Experience with complex products, especially in catheter-based or cardiac assist devices, is preferred. Quality Control Experience: You should have experience with formal problem-solving methodologies, deductive skills, and handling non-conforming materials or assemblies. Regulatory Knowledge: A solid understanding of FDA QSRs, ISO13485, Ordinance 169, ISO14971, and similar regulations is essential.
Role: Data Analyst, Clinical Business operations
Job Description Our company is seeking a Data Analyst to assist in Clinical Business Operations (CBO) data entry. This role will be responsible for managing the migration of CBO data from internal data sources into CBO developed applications. This role will follow a quality control process to ensure the completeness and integrity of the data, work with teammates and management on complex data entries and provide feedback on the CBO developed applications and workflow. Cross functional outreach may be a component of this role.
Essential Functions of The Job
» Enter CBO data and other relevant data into the CBO developed applications
» Collaborate closely with teammates and management on data entry quality control process and process improvements
» Review CBO developed applications entered data for accuracy and completeness
» Compile, verify, and sort information to prepare source data for entry
» Research and obtain missing documents needed for data entry
» Perform data reconciliations to identify data anomalies
» Escalate data issues needing process re-engineering
» Perform data quantitative and qualitative analysis
» Assist in maintenance, back up and security of business data
Requirements Education: BA/BS or the equivalent in work experience Computer Skills: Advanced Microsoft Excel user, Database/Data Warehouse experience preferred, Adobe, Microsoft Office: Outlook, PowerPoint, Visio, Word, Smartsheets, One-Note Other Qualifications: Strong communication and organization, strong data analysis, attention to detail, 65+ WPM typing, intermediate in Excel
Role : Java Developer Duties: » Designing, coding, testing, and debugging complex software applications using Java » Collaborating with product owners, business analysts, and other stakeholders to gather requirements and translate them into technical specifications » Developing and maintaining software documentation including design documents, technical specifications, and user manuals » Participating in code reviews to ensure code quality and adherence to coding standards » Troubleshooting and resolving software defects and issues » Mentoring junior developers and providing technical guidance as needed » Keeping up-to-date with the latest industry trends and technologies » Travel: Minimal Qualifications: » Bachelor's degree in Computer Science or related field (or equivalent experience) » 10+ years of experience as a Senior Java Developer or similar role » Strong knowledge of Java programming language and related frameworks » 5+ years of experience with Web Application, Service, or back-end development » Experience with Cloud platforms, including AWS or Azure » Experience with containerization technologies, including Docker and Kubernetes » Experience with building and maintaining APIs and API documentation » Experience with CI/CD tools » Experience w/Agile software development methodologies and tools, including Git & Jira » Experience with Golang, Rust, or Python » Experience with front-end frameworks, including Svelte, React, or Angular » Experience with GitHub and GitHub Actions » Experience with creating software ideas and tools from scratch
