Quality Manager - Rossens, Switzerland
About Us
ILC Dover, part of Ingersoll Rand, is a world leader in innovative design and production for biopharmaceutical, pharmaceutical, medical device, and aerospace markets. For over 25 years, we’ve led the industry in single-use powder and liquid handling, solving life sciences’ most complex bioprocessing challenges. We uphold our mission to deliver custom containment solutions so you can uphold your mission to deliver life-saving therapies.
Job Summary
Reporting to the Director of Quality Operations, BPS, the Quality Manager is responsible for leading and maintaining the Quality Management System (QMS), ensuring compliance with ISO 9001 and applicable global business, customer, regulatory, and industry requirements. The role oversees quality assurance, quality control, supplier quality, audits, certification activities, calibration and metrology programs, and continuous improvement initiatives. The position partners with operations, engineering, purchasing, and leadership teams both locally and globally to ensure project and product quality, regulatory compliance, and operational excellence.
Key Responsibilities
Quality Management System
- Lead, maintain, and continuously improve the ISO 9001 Quality Management System in compliance with the ILC Dover Global Business Management System (BMS)
- Develop, update, and control quality procedures, work instructions, records, and documentation.
- Monitor compliance with applicable standards, certifications, and customer requirements.
- Coordinate internal and external audits and support certification activities.
Quality Assurance & Quality Control
- Ensure all project activities start and finish with the customer:
- From documented, agreed-upon requirements to documented, evidence-based verification/validation all while enforcing rigorous two-party-approved change control
- Oversee incoming components, in-process sub-assembly, supplier, and final installation inspections.
- Establish and maintain quality control processes and acceptance criteria.
- Review quality performance metrics and drive corrective and preventive actions.Investigate nonconformances, customer complaints, and process failures using root cause analysis.
- Support acceptance, calibration, metrology, and certification activities.
Supplier & Operational Quality
- Partner with Global Supplier Quality Management, Operations, Engineering, Purchasing, and Suppliers to improve quality performance.
- Support and ensure effective implementation of quality requirements throughout the project and product lifecycle.
- Verify compliance with established quality standards and procedures.
Leadership & Continuous Improvement
- Lead and develop quality personnel and cross-functional teams.
- Promote a culture of quality awareness and accountability.
- Lead continuous improvement initiatives, Kaizen activities, and quality system enhancements.
- Communicate quality performance, risks, and improvement opportunities to management.
Audit & Compliance
- Serve as the primary contact for regulatory agencies, certification bodies, and customer audits.
- Ensure audit readiness and maintenance of an auditable QMS.
- Support compliance with food safety, pharmaceutical, environmental, safety, and customer requirements where applicable.
Authority
- Stop production when quality requirements or procedures are not being followed.
- Conduct internal audits.
- Initiate and lead corrective actions and continuous improvement activities.
- Approve quality-related documentation and certifications.
Education & Experience
- Bachelor’s degree in Engineering, Quality, Science, Management, or a related discipline; Master’s degree preferred.
- 5-10+ years of experience managing quality systems in a manufacturing, medical device, pharmaceutical, or regulated environment.
- Experience leading audits, supplier quality activities, CAPA systems, and quality improvement programs.
- ISO 9001 Lead Auditor certification preferred. Additional certifications (ISO 13485, FSSC 22000, Six Sigma) are advantageous.
Key Competencies
- Quality Management Systems (ISO 9001)
- Audit and Regulatory Compliance
- CAPA and Root Cause Analysis
- Supplier Quality Management
- Quality Metrics and Data Analysis
- Continuous Improvement / Lean / Six Sigma
- Leadership and Team Development
- Strong Communication and Cross-Functional Collaboration
- Excellent Organizational and Documentation Skills
- English and French proficiency required.
Travel & Work Arrangements/Requirements
- Hybrid working, with occasional travel to customer sites for FAT/SAT activities
What We Offer
- 25 Days Annual Leave
- 10% of salary in shares after 1 year of employment
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