QMS/CAPA Engineer

Responsible for supervising the QMS team, ensuring efficient execution of quality management system (QMS) activities in compliance with company policies. The role monitors key quality performance indicators, analyzing data to identify trends and areas for improvement, and reporting to higher management. The role ensures timely process implementation and deployment, tracking progress and verifying effectiveness. The role conducts risk assessments and manages mitigation activities, developing strategies to minimize impact and facilitates cross-functional collaboration to resolve quality issues. The role drives continuous improvement initiatives within the QMS, proposing enhancements to processes, tools, and systems, guiding the QMS team to achieve operational goals. additionally, an active participation in CAPA facilitation is required

Your role:

• Supervises day-to-day operations of the QMS team, ensuring all quality processes are executed efficiently and in compliance with company policies and other necessary requirements.
• Manages the deployment and maintenance of QMS processes in the assigned area/ areas such as document control, training, and internal audits, ensuring they are effective, compliant, and aligned with both regulatory requirements and business needs.
• Monitors and reports on the effectiveness of QMS processes by analyzing performance metrics, identifying trends, and developing action plans to address gaps, enhance compliance, and improve overall quality.
• Prepares for and supports external audits and inspections by ensuring all necessary documentation is available and providing detailed responses to audit findings.
• Facilitates cross-functional collaboration to resolve quality-related issues, working closely with other departments to ensure alignment and effective problem-solving.
• Manages the documentation and resolution of non-conformance reports (NCRs), ensuring systematic tracking, effective resolution, and implementation of preventive measures to avoid recurrence.
• Conducts risk assessments and manages risk mitigation activities, identifying potential risks to product quality and QMS integrity, and developing strategies to minimize their impact.
• Drives continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to improve overall quality performance and operational efficiency.
• Addresses difficult to moderately complex issues or problems, requiring the evaluation of identifiable factors, following established processes and operational policies in selecting methods and techniques for obtaining solutions.
• Guides and mentors the QMS team, actively contributing to employee selection, performance management, compensation management, career development, and overseeing operational processes.
• Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
• Manages CAPAs as CAPA engineer

You're the right fit if: (4 x bullets max)

1. Experience- 10+yrs of experience in Medtech industry.

2. Skills-

• German writing/speaking - preferred
• English writing/speaking skills - must
• Regulatory Requirements
• Quality Management Systems (QMS)
• Project Management
• Data Analysis & Interpretation
• Process Improvements
• Technical Writing
• Training Content Development

3. Education\- Bachelor's / master’s degree, in engineering/science field or equivalent.

4. Anything else- Master's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

Onsite roles require full-time presence in the company’s facilities.

Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

Indicate if this role is an office/field/onsite role.