Systems Quality Engineer II

Job Description

The Systems Quality Engineer II will support the implementation and improvement of the integrated quality management system to ensure it is compliant with applicable global Quality System regulations (i.e., 21 CFR Part 820, ISO 13485 : 2016, MDR etc.). They will ensure that the solutions are effective and efficient while also providing functional and technical support to the project team.

Main Responsibilities

Support the design, development, maintenance and continuously improve the TMC Quality System in accordance with applicable regulations for a global medical device corporation.

Help to establish user and system requirements.

Support the definition and validation of user and system requirements to ensure the successful implementation and performance of the electronic Quality Management System (eQMS)

Gather and analyze data to support effective planning for the implementation of the electronic quality management system (eQMS).

Leverage data analytics to inform planning and optimize the implementation of the electronic Quality Management System (eQMS), ensuring alignment with organizational goals and regulatory requirements.

Provide technical and functional expertise to teams before, during and after implementation phases.

Provide exceptional user support during the planning and execution of implementation phases.

Contribute to the development of Quality System Standard Operating Procedures, Work Instructions and training materials as required.

Contribute to the development of Quality System performance metrics to demonstrate performance of the quality system.

Follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Other duties as assigned.

Organizational Impact :

This role will support the integrity and continuous improvement of the company’s global Quality Management System (QMS). By supporting the design, development, and maintenance of compliant and efficient quality systems, this role directly contributes to the organization’s ability to meet regulatory requirements such as 21 CFR Part 820 and ISO 13485 : 2016. This role supports cross-functional teams by providing technical and functional expertise during the implementation and optimization of the electronic quality system (eQMS).

Communication & Influence :

The Systems Quality Engineer II communicates regularly with cross-functional teams including Quality, Regulatory, IT, Operations, and Engineering to support the implementation and continuous improvement activities related to the Quality Management System and eQMS. This role requires the ability to clearly articulate technical and functional concepts to both technical and non-technical audiences through written documentation, training materials, and verbal presentations.

The engineer will provide guidance, support project direction and system design through data driven and objective means to align stakeholders on quality initiatives, resolve implementation challenges, and drive adoption of quality system improvements. The position also contributes to the development of performance metrics and development or updates of standard operating procedures.

Innovation & Complexity :

This role is expected to address varied challenges related to the design, implementation, and continuous improvement of the Quality Management System. Much of this role will require critical thinking and adaptability to navigate evolving requirements and cross-functional project demands.

This role involves analyzing data and developing innovative solutions that enhance system efficiency and effectiveness. The role must be comfortable with some level of ambiguity during system implementations and upgrades, often working with incomplete information to propose effective and compliant solutions. Success in this role depends on the ability to balance project team needs, compliance, and value-added but efficient processes.

Leadership & Autonomy :

This position does not include direct people management responsibilities.

This role is expected to operate with a high degree of autonomy while managing multiple tasks and priorities with minimal supervision. The role requires initiative in identifying opportunities by analyzing data, stakeholder feedback and proposing solutions that align with compliance requirements and organizational goals. The ability to work independently and influence cross-functional teams is essential to the success of this role.

Position Requirements :

Knowledge, Skills and Abilities (KSAs) :

• Knowledge in 21 CRF Part 820, ISO 13485 : 2016, Medical Device Directive / Regulation.
• Strong computer knowledge (MS Office), technical writing skills and proofreading ability.
• Ability to develop, communicate, and support the implementation of comprehensive quality systems.
• Ability to analyze data utilizing Power BI, Excel, Minitab, or other data analytical software.
• Ability to navigate implementing products and processes in an efficient and compliant manner.
• Demonstrated ability to interact cross functionally within the organization.
• Demonstrated initiative and ability to work independently while handling multiple tasks.
• Strong decision-making and prioritization skills.
• Strong written, verbal, and interpersonal communication skills.
• Strong organizational and presentation skills.

Background Experiences :