Suvoda

SaaS-driven IRT for clinical trials

Quality Engineer - Systems & Compliance

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeRemote in RomaniaNo salary listedRemote

About the Job

Requirements

Proficiency in English, including strong oral and written communication and technical writing capabilities.
One to three years of experience in a GxP compliance and/or quality-related role is preferred; this is a preferred qualification, not a required minimum.

Responsibilities

Manage and facilitate all stages of the Quality Event Management process, including incident and issue investigations, risk and impact assessments, trend analyses, and corrective and preventive actions with effectiveness checks.
Conduct quality event investigations by facilitating and completing root cause analyses, collecting and analyzing data with cross-functional teams, applying root cause analysis tools such as flowcharts, fishbone diagrams, and 5-Why analysis, and ensuring investigations comply with GCP requirements. Apply corrective and preventive action disciplines to develop effective action plans.
Review quality event trends, facilitate analyses, and escalate observations when warranted by the Quality Management System process.
Prepare client-facing communications and Quality Event Investigation Reports, adapt technical investigation details for non-technical audiences, and communicate investigation progress to stakeholders as needed.
Conduct risk assessments and facilitate impact analyses in response to Quality Event Investigations.
Attend weekly Issue Management Team meetings, prepare meeting slides, take notes, and follow up on actions as required.
Prepare and evaluate quality-event data for audits and audit findings, and work cross-functionally to implement process improvements.
Develop and maintain key performance indicators and calculate performance using available data to support continuous improvement of the quality management system.
Collaborate with teams to develop and revise standard operating procedures, work instructions, guidelines, forms, templates, and knowledgebase articles to continuously improve the Quality Management System.
Create internal stakeholder reports on product and process performance and the status of Quality Event Investigation activities using Excel and PowerPoint.

Desired Qualifications

A bachelor's degree in a science-related field is preferred.
Knowledge of process improvement techniques is preferred.

Suvoda is looking for a Quality Engineer to join our team and help ensure the quality, reliability, and performance of our solutions. In this role, you’ll collaborate with cross-functional teams to support quality assurance activities, identify opportunities for improvement, and contribute to delivering high-quality products that meet our standards and customer expectations.

Responsibilities:

Manages and facilitates all stages of the Quality Event Management process, including but not limited to, conducting incident/issue investigations, assessing risk/impact, conducting trend analyses, and defining and tracking corrective and preventive actions and associated effectiveness checks.
Conducts Quality Event Investigations by facilitating and completing root cause analyses: working internally with cross-functional teams to collect and analyze relevant data, utilizing and applying RCA tools (such as flowcharts, fish bone diagrams, 5-Why's analysis, etc.) and ensuring that investigations are conducted in accordance with a GCP-regulated environment. Applies CAPA disciplines to develop effective corrective and preventive action plans.
Performs quality event trend reviews and facilitates analyses, escalating observations when deemed warranted by QMS process.
Produces client-facing documents/communications, such as Quality Event Investigation Reports; adapting highly technical investigation details for a non-technical audience and communicating investigation progress updates to stakeholders when needed.
Conducts risk assessments and facilitates impact analyses in response to Quality Event Investigations.
Attends weekly Issue Management Team meetings. Prepares slides for the meetings, takes notes during meetings, and follows up on actions from the meeting, as required.
Prepares and eEvaluates data pertaining to quality events in preparation of audits and in response to audit findings, working and works cross functionally with teams to implement process improvements as needed.
Develops and maintains key performance indicators (KPIs) and calculates performance based on data from available sources to support the continuous improvement of the quality management system.
Works with teams to develop new processes in the form of SOPs, Work Instructions, Guidelines, Forms, Templates and knowledgebase articles. Likewise, performs reviews and revisions of current processes in the form of SOPs, Work Instructions, Guidelines, Forms, Templates and knowledgebase articles to ensure continuous improvement of the Quality Management System.
Creates internal reports for stakeholders that provide insight and value regarding product and process performance and/or the status of Quality Event Investigation activities using a combination of Excel and PowerPoint.

Requirements:

Bachelor’s degree in science-related field preferred
High-achieving personality
Desire to learn, grow, and develop
Strong work ethic and sense of ownership
Highly analytical with fine attention to detail
Proactive attitude
Strong time management and organization skills
Ability to practice risk-based judgement
Excellent oral and written communication skills and technical writing capabilities; Proficient in English.
Knowledge of Process Improvement techniques preferred

Experience:

1-3 years of experience in a GxP compliance and/or quality-related role preferred

We are aware that an individual(s) are fraudulently representing themselves as Suvoda recruiters and/or hiring managers. Suvoda will never request personal information such as your bank account number, credit card number, drivers license or social security number — or request payment from you — during the job application or interview process. Any emails from the Suvoda recruiting team will come from a @suvoda.com email address. You can learn more about these types of fraud by referring to this FTC consumer alert.

As set forth in Suvoda’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

If you are based in California, we encourage you to read this important information for California residents linked here.

About the Company

Suvoda

SaaS-driven IRT for clinical trials

Suvoda provides a modular SaaS platform for managing complex clinical trials through an Interactive Response Technology (IRT) system. It handles patient randomization, drug supply management, and trial data collection, and offers virtual trial capabilities such as direct-to-patient shipping. The modular design lets customers configure and deploy the system quickly, often in about four weeks, with ongoing updates and support. Its goal is to help pharmaceutical companies, biotech firms, and CROs run complex trials more efficiently and speed the introduction of new treatments by offering flexible, rapid-start solutions.

Company size: 1,001-5,000
Company stage: Early VC
Total funding: $40M
Headquarters: Conshohocken, PA
Founded: 2012

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