Roles and Responsibilities:

Description: Performs diverse and complex assignments in support of GEHC product development and manufacturing. Assignments may include, but are not limited to: set up and running of data acquisition equipment for tests, carrying out experiments, and reporting/documenting results of tests and measures.

Essential Responsibilities

Test production assemblies and sub-assemblies for correct operation and compliance to performance specifications

Interfaces with other departments in the execution of duties to ensure the orderly flow of material and information

Construct and assist in evaluating engineering models

Perform basic trouble shooting encompassing multiple variables and unknowns to achieve root cause analysis and problem resolution. Conduct experiments and diagnostic tests, as required to draw conclusions

Perform software and hardware evaluation and implement plans using knowledge of product, system operation, intermodule interactions, engineering tolls, and interactive software tools as required

Utilize basic technical communications throughout the new product cycle to improve internal models and/or externally sourced components in terms of system performance, reliability, functionality, and serviceability

Provide evaluation, constructive feedback and leadership in the development of internal and external engineering, manufacturing, or service documentation

Develop and execute training plans as required

Comply with EHS regulations and policies

General direction is given in the execution of job related activities

Associates degree (or local equivalent 2 year degree), or a High School diploma (or local equivalent) and 2 or more years technical experience

Proficiency to logically troubleshoot at subsystem and system level, using identifiable problem solving techniques

Ability to draw accurate conclusions from test data, malfunctions, or deviations, and assist with corrections to the existing design or process

Proficiency to understand and interpret basic written technical information

Demonstrated ability to work well with limited direction and information

Ability to communicate using local language

Project Planning & execution:

• Develop and manage comprehensive project plans for supplier transfers including timelines, budgets, and resource allocations.

• Define project scope, objectives, and deliverables in alignment with business goal.

• Coordinate cross-functional teams including sourcing, engineering, quality, operations, and QARA.

• Monitor and track project progress, identifying and mitigating risks and issues throughout the lifecycle of the program.

• Lead regular project meetings, reporting status and providing regular updates to stakeholders and leadership teams.

• Ensure compliance to GEHC QMS and industry standards.

• Work closely with suppliers to ensure smooth transition, including knowledge transfer, validation and capability/ readiness assessments.

Risk Management & Compliance:

• Identify risks associated with supplier transfers and develop mitigation strategies with the program team.

• Ensure adherence to regulatory requirements including GEHC QMS standards and international medical device regulations and quality standards (ISO 13485, FDA 21 CFR Part 820, EU MDR, China NMPA, Japan PMDA) and other industry best practices.

• Conduct risk assessments (DFMEA, PFMEA) and implement contingency plans to prevent disruptions/ impacts to the program’s deliverables.

• Work with regulatory and quality teams to maintain documentation and approvals required for compliance.

Cost and Performance Management:

• Manage project budgets, ensuring cost efficiency while meeting performance goals.

• Optimize supply chain strategies to reduce costs, improve efficiency and maintain product quality.

• Track supplier performance post-transfer/implementation, identifying corrective actions if necessary to ensure long-term supplier sustainability.

Required Qualifications:

• Bachelor’s degree in Engineering, Supply Chain, Business Management or related field.

• Proven track of project management experience in supplier transfer, supply chain or manufacturing, preferably in the medical device industry.

• Experience managing global program teams and working across different time zones, cultures and regulatory landscapes.

• Experience in regulated industries such as medical devices, pharmaceuticals, aerospace, automotive.

• Strong knowledge of medical device manufacturing processes, validation and quality systems.

• Strong project management skills with experience in tools like MS Project and/or Smartsheet.

• Knowledge of supplier qualifications, validations and risk management.

• Strong problem-solving, negotiation and communication skills with the ability to work effectively across different cultures and time zones.

• Ability to manage multiple programs in parallel.

• PMP, Six Sigma, and/or Lean Manufacturing certification is a plus

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.

Qualifications

• Bachelor’s degree or higher. Beneficial with technical degree.
• Working proficiency in writing and speaking English, proficiency in Norwegian is considered an advantage.
• Experienced in the area of engineering release and change process.
• Previous experience related to project management and planning would be considered an advantage.

Essential Responsibilities

• In close collaboration with program teams create product structures and item attributes for compliance with GE HealthCare procedures and national regulations for new and existing products.
• Drive design releases to manufacturing and own design change implementations according to company procedures and plans.
• Drive software update design change, including facilitation of electronic delivery of software updates.
• Creation and release of commercial product items and facilitate for product releases in content management system.
• Ensure changes are according to company quality and regulatory policies.
• Manage change notifications and distribute change documentation to suppliers.
• Participate in quarterly planning sessions with R&D to define and prioritize on deliverables together with the Design Change Control team.

Personal qualities

• You are a positive person with good team and cooperative skills.
• You are systematic and analytical by nature with attention to details.
• Ability to take ownership, be proactive and pivot between priorities in a dynamic environment.
• You are not afraid of questioning and taking responsibility in you daily work.
• You are skilled in working with software-based tools, specifically content-management

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

• Contribute to the definition of the electronic design topology of future generation ultrasound probes

• Definition and design of electronics based on user needs and system requirements.

• Contribute on finding new opportunities from technology trends.

• Drive design, quality and reliability best practice work flows and documentation and implementing them to improve current and new products.

• Assist the electronics HW team as an expert resource in their daily work and contribute with hands on work related to design, prototyping and debugging.

• Master’s degree in electrical engineering or related field

• Proven experience from design and development of electronic receivers, transmitters, AD-converters, FPGAs, uControllers or processors.

• Proven excellency of teamwork, coordination and communication skills

• In-depth knowledge of best practices and how electronics integrate with others.

• Demonstrated ability to analyze and resolve problems.

• Excellent English proficiency, both oral and written

• Experience from electronic designs used in ultrasound applications.

• Experience from design of analog electronics (filters, amplifiers, power regulation)

• Experience from design of digital electronics and FPGA (clock distribution, VHDL, Verilog)

• Experience from Layout of PCBs

• Experience from design development according to standard IEC60601-1

• Experience from FW programming and use of uControllers (C, C++)

• Experience using scripting languages (Python)

• Experience from SW system design

• Experience using Linux systems.

• Work with products that make a difference in people’s life, improving the GE Healthcare medical products.

• Work with and learn from world leading experts in ultrasound imaging – in a team with great spirit.

• We offer the possibility to work in a diverse multicultural working environment.

• Technical career growth opportunities through specialized technical career path process.

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.

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.

Essential Responsibilities

• Provide scientific and technical expertise, oversight and leadership of the team to develop and validate analytical methods within the department’s priorities. Other techniques and methods are also applicable depending on the team members competence.
• Ensure priorities of the team are appropriately resourced with right level of competence, and that the team has the facilities and tools needed.
• Maintain an up-to-date knowledge and understanding of current GxP, EHS and Lean requirements within the department’s responsibility. Continued drive for improvement.
• Responsible for the scientific, quality and regulatory compliance of the team’s deliveries through review and approval of analytical methods, validation protocols/reports, and scientific studies in accordance with GMP and applicable regulatory guidelines.
• Personnel and administrative responsibility for the team and develop/coach the team members.
• Proactively plan and collaborate to ensure compliant, efficient, competitive delivery of the analytical needs of the business.
• Be a key leader collaborating and driving change to deliver patient needs for both marketed and new product introduction.

Required Qualifications

• MSc in Chemistry/Biochemistry or similar qualifications, preferably with knowledge and experience with the analytical techniques the team is responsible for.
• Strong experience in analytical method development and validation, and good understanding of GMP and the regulatory requirements.
• Experienced with current Good Manufacturing Practice (GMP) requirements.
• Good knowledge about establishment and justification of pharmaceutical product specifications.
• Strong interpersonal skills, team player, able to build network across teams.
• Demonstrated problem-solving skills.
• Strong English written and spoken communication skills.

Desired Characteristics/Skills

• PhD in Chemistry/Biochemistry
• People and project leadership experience, but candidates who want to develop into a leadership role are also encouraged to apply
• Collaborate with internal and external partners
• Build networks of contacts inside and outside the organization
• Hands on analytical chemistry experience and ability to perform tasks in the lab if required.

Our total rewards are designed to unlock your ambition by giving you the drive 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.

At GE HealthCare, the request for medical certificates of non-pregnancy and Human Immunodeficiency Virus (HIV) as requirements for entry, permanence or promotion in employment is prohibited.