QMS Process Engineer
About The Position
The QMS Process Engineer delivers operational excellence for specific Critical-to-Quality (CtQ) ecosystems by executing fit-for-purpose quality activities and driving the delivery and sustainability of a robust Quality Management System (QMS). The role partners across teams to design, implement, and optimize clear, data-driven execution workflows; integrates digital enablement, AI, and automation tools to streamline processes; and turns quality data into structured insights through trend analysis. The position maintains alignment with global regulatory standards, including GxP, Pharmacovigilance, and IVD/Medical Device regulations, and embeds CtQ principles into system design. It also supports inspection readiness and regulatory intelligence analysis, assesses the impact of emerging regulations, and engages multidisciplinary stakeholders to guide compliant, sustainable process updates.
Requirements
- Bachelor’s degree in a scientific or quality-related field, or equivalent practical experience.
- Professional experience in a regulated GxP environment.
- Strong foundational understanding of process engineering frameworks such as Lean or Agile.
- Data analytics and quality data storytelling skills, including experience using data to solve operational challenges and substantiate recommendations.
- Proactive self-starter with critical-thinking skills, able to navigate ambiguity and take ownership to bridge operational gaps.
- Strong communication and relationship-building skills, with the ability to influence without formal authority and partner effectively across teams.
Responsibilities
- Deliver operational excellence for specific Critical-to-Quality ecosystems by executing fit-for-purpose quality activities.
- Drive the delivery and sustainability of a robust Quality Management System.
- Partner across teams to design, implement, and optimize clear, data-driven execution workflows.
- Integrate digital enablement, AI, and automation tools to streamline processes.
- Analyze quality data and trends to identify actionable operational patterns and develop structured insights.
- Maintain alignment with global regulatory standards, including GxP, Pharmacovigilance, and IVD/Medical Device regulations.
- Embed Critical-to-Quality principles into system design.
- Support inspection readiness and regulatory intelligence analysis, including assessing the impact of emerging regulations.
- Engage multidisciplinary stakeholders to guide compliant, sustainable process updates.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided in the job posting.
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What This Job Offers
Job Type
Full-time
