דרושים Systems Test Engineer ב-Ge Healthcare ב-Norway

Description

The Quality Assurance manager - QA systems is responsible for managing the processes associated with Quality Assurance systems, to assure product safety and quality by driving business alignment to cGMP, regulatory & product license requirements and business objectives by managing quality systems, controls and continuous improvements.

Quality Assurance manager - QA systems will engage with the relevant support departments and build strong relationships with same.

You will demonstrate Role Model Leadership by facilitating, coaching, mentoring and developing your team.

Key responsibilities

• Owning the processes associated with the deployment of global policies and site quality procedures. Ensuring quality and site procedures are up to date and reflective of regulatory & industry and GE Healthcare internal standards requirements.
• Responsible for the overall quality risk management at site to assure product quality, patient safety & efficacy.
• Management of the processes of internal and external inspections, including Inspection readiness preparation, inspection execution and ensuring non-conformances are actioned & progressed to closure in a timely manner.
• Responsible for engaging strong intradepartmental and cross-functional / organizational relationships to drive quality system requirements.
• Driving site Regulatory Intelligence processes to ensure timely compliance with Regulatory requirements.
• Influencing site compliance to Quality policy, Quality Management System procedures, regulatory requirements, Product License Requirements and cGMP.
• Responsible for Quarterly Management Review process, analyzing the trend reports, identifying actions / gaps & driving continuous improvements.
• Driving EHS performance in the department in accordance with the requirements of the company’s 5S, safety and environmental management programs.
• Driving GMP training on site.
• Managing and/or support quality programs for Computer Software Validation, Data Integrity and Lifecycle for Analytical Method validation

Reporting lines:

Quality Assurance manager - QA systems report to the Director of Quality Operations

Required Qualifications

• Master’s degree , preferable within Life Science or Pharmacy.
• Proven track of Quality experience in the pharmaceutical industry
• Proven track of supervisory/management experience
• Experience with regulatory inspections
• Demonstrated experience with regulations in the pharmaceutical industries and knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
• Strong oral and written communication skills in both Norwegian and English.
• The role requires physical attendance at the Oslo site

Required Characteristics

• Strong interpersonal and leadership skills
• Results orientated with a strong ability to effectively troubleshoot, and problem solve issues
• Exceptional planning skills to consistently deliver stretch targets and objectives

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Support application owners on keeping systems in validated state

• Make sure master data is made available and utilized amongst applications

• Maintain and enforce policies for access on all levels

• Data Governance with special emphasis on actual usage and purpose in a GxP environment.

• ETL/ELT processes from local data sources to AWS

• Support ML teams on data infrastructure issues, e.g an ML-OPS framework (ML=Machine Learning)

• Trouble shooting of inter-application issues

• Migration (scripts) for changes to MS-SQL databases

• This role requires advanced experience in work with Historian and PI functionality and data analytics. Knowledge level is comparable to a Bachelor's/Master's degree from an accredited university or college (or a high school diploma with relevant experience)

• SQL server management studio (or corresponding)

• SQL Server Reporting Services

• Database optimization

• Database security/policies

• Familiar with OSI soft PI (AVEVA PI)

• Familiar with Historian databases

• Competence in Power BI

• Various Web API technologies

• ML-OPS( Machine learning )

• General .Net, C# App/Web development

• Thrives in formal, controlled environments

• Patience when it comes to work process improvements

• A bias for Documentation and Accuracy

• Communication Skills: ability to both receive and transfer oral and written information from / to various professional fields like quality and chemistry.

• Integrity and Ethics; a no-nonsense attitude towards rules and regulations

• Technical curiosity: A drive to exploit the properties and functionality of any given platform.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Responsibilities

• Being active participant in development of the new functionality by taking part in review of requirements, writing and execution of tests
• Perform verification of code commits and additional exploratory testing prior maintenance releases to prevent critical issues going to customers and improve quality of the product
• Take part at new product Formal Verification activities
• Perform investigation of issues received from customers

Qualifications and experience

• Bachelor or Master’s degree in Computer Science, Software Engineering, or related equivalent/experience.
• Experience with testing tools and general system testing
• Good team and communication skills
• Self-motivated, communicable, result oriented, and able to multi-task

Desired skills

• Experience in any of these fields would be considered as an advantage in your application
• Experience with medical equipment
• Knowledge of Python programming language

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Roles and Responsibilities

• Develop applications and software for ultrasound systems, focusing on the system frontend handling transmit, receive, and processing of ultrasound data.

• Design, implement, and test ultrasound system software, hardware, and probes.

• Engage in all phases of new product development from concept to release, and service support.

• Produce high quality technical documentation, adhering to the stringent standards of the medical industry.

• Contribute to global development projects within GE HealthCare, leveraging cross-functional expertise and collaboration.

Qualification/Requirements

• Master’s or Ph.D. degree in Computer Science, Software Engineering, Physics, Cybernetics, Electrical Engineering, Signal Processing, Medical Imaging or related discipline.

• Proficiency in object-oriented design and C/C++ programming, with a solid understanding of real-time performance and data throughput in computationally intensive applications.

• Experience in firmware programming and use of microcontrollers (C, C++).

• Demonstrated problem solving abilities.

Preferred Skills

• Direct experience in R&D and ultrasound system development for cardiology applications such as diagnostic echo, transesophageal echo, and intracardiac catheters.

• Experience using MATLAB/Python for rapid prototyping.

• Proficiency in modern software development best practices, including Test-Driven Development (TDD).

We are looking for doers with

• Strong written and verbal communication skills.

• Self-motivation, result orientation, and ability to take initiative in a multi-task environment.

• Awareness of product quality and reliability.

• Capability to drive projects as both leader and contributor.

• Clinical exposure, or a willingness to collaborate with clinicians.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

Senior Engineer - TEE Probes Transfers Program Management

As a Senior Engineer in the TEE Probes Transfers Program Management, you will work within a global team to support design and manufacturing transfer activities from the Design Owner Site in Horten, Norway, to State College, US. This role involves partnering with a transfer leader from the receiving site (State College) and representing the Design Office for TEE probes and collaborating horizontally with the manufacturing transfer program manager.

Responsibilities:

• Program Management: Develop and manage cross-functional, technology-led, or product-focused programs or transfer programs. This includes managing budgets, interfacing with contractors, suppliers, customers, and internal functions, and overseeing program resource and budget allocation/integration. You will also manage schedules, budgets, and the tollgate process for NPI, requisition, or sustaining programs, ensuring they meet customer CTQs.
• Technical Expertise: Develop in-depth knowledge of a technical discipline, using prior experience and acquired technical expertise to execute policy and strategy.
• Business Integration: Understand key business drivers and how your team's work integrates with other teams, contributing to the overall area.
• Problem-Solving: Use judgment to propose different solutions outside of set parameters with guidance. Utilize prior experience and on-the-job training to solve straightforward tasks, accessing technical skills and analytic thinking required to solve problems. Collaborate with multiple internal sources outside of your team to make decisions.
• Program Coordination: Coordinate and drive programs and work packages, working with horizontal teams in the AVS Ultrasound Probes organization, as well as partners in manufacturing, advanced manufacturing engineering, suppliers, and third-party vendors, to ensure the successful manufacturing transfer from Horten, Norway, to State College, US.
• Project Planning: Contribute to and own planning for program and work packages in complex transfer projects. Likely own some transfer workstreams, representing the TEE Design Office Horten, structuring and harmonizing all requests and inputs to the engineering team as the first point of contact. Drive the definition of scope, schedule, and critical-to-quality features.
• Self-Management: Manage your time effectively, set goals, organize work, focus on customer needs, and build professional relationships.

Qualifications:

• Experience: Advanced experience in Engineering/Technology & Program Management. Knowledge level comparable to a Bachelor's degree from an accredited university or college, or a high school diploma with relevant experience.
• Skills: Strong analytical and problem-solving skills, creativity in finding solutions, and proficient computer skills including Microsoft Project, Excel, PowerPoint, and Word for documentation and capturing inputs and outputs.
• Communication: Demonstrated interpersonal and communication skills, including relationship building, written and verbal communication, and active listening.

What we offer:

• A highly interesting position at the market leader in ultrasound
• A purposeful and international environment in a growing company
• Flexible working arrangements with the possibility for hybrid working
• You are owning and driving you career development
• Part-time work or job sharing can be considered

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

• Be the Quality Assurance lead resource within Manufacturing Transfer projects, both for internal transfer projects (between GEHC sites), as well as transfers to external (non-GEHC) Manufacturing sites.

• Ensure compliance to the GE Healthcare Quality Management system under ISO 13485, and other applicable standards and regulation. Be the reviewer and approver of QMS documentation and deliverables throughout all phases of the transfer project.

• Efficiently interact and cooperate with the Transfer Program Manager, Manufacturing, Engineering and Regulatory Affairs, from project initiation until completion. Manage planning of the Quality Assurance deliverables within the transfer projects, and ensure progress to plan.

• Partner with GE Healthcare Subject Matter Experts to identify solutions that are both lean and compliant to standards and regulation.

• Where applicable, provide Quality Assurance support for external transfers (non-GEHC), post implementation.

• Resolve compliance conflicts within the projects.

• Bachelor’s degree in engineering or other relevant discipline

• Experience (3+ yrs) in the field of Quality Assurance

• Demonstrated ability to plan, lead and execute projects

• Solid problem-solving skills (ability to manage and resolve conflicts and propose solutions to both internal team members and external clients)

• Operational mindset and ability to translate strategy into action, with strong sense of urgency to drive outcomes with speed and efficiency

• Understanding of change management processes

• Proficient skills within computer-based platforms and tools, e.g. Salesforce, MS Office

• Strong oral and written English communications skills

• Willingness to travel internationally, when needed in transfer projects.

• Prior experience in Healthcare industry

• Experience within ISO 13485 Medical Device Quality Management standard and Medical Device regulation, e.g. 21 CFR 820

• Prior experience in roles with demonstrated team orientation & ability to motivate and work well with diverse, cross- functional teams in matrixed settings

• Experience from change management projects

• Strong presentation skills

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.