Operations Systems Specialist

Job Overview

At Tecan, we're committed to improving people's lives and health by empowering our customers to scale healthcare innovation globally. We're seeking an experienced Quality Operations Specialist to join our team and play a pivotal role in maintaining the integrity and excellence of our production processes.

Duties and Responsibilities

As a Quality Operations Specialist, you'll be instrumental in driving process stability and quality improvement initiatives while ensuring compliance with industry standards and regulations. Your responsibilities will include:

1. Continuously developing and guiding production to enhance process stability and quality.
2. Quality Operations responsibility for specified product lines, including the distribution release of instruments (Final Inspection, DHR Examination).
3. Representing the QO department in relevant projects, product team meetings, and production activities.
4. Coordinating, conducting, and concluding Complaint, Nonconformity, and CAPA investigations with relevant internal departments and suppliers for defined product lines.
5. Leading and organizing Task Forces resulting from investigations to initiate or accompany short-term corrective actions.
6. Ancillary to regulatory requirements, assessing deviations regarding reporting obligations in cooperation with the Global Complaint Unit and Regulatory Affairs based on investigation results.
7. Implementing the Quality Management System.
8. Generating and evaluating statistics (based on Complaints, CAPAs, NCRs, and FPY).

Requirements

We're not just looking for hard skills: We're looking for people who bring their passion and talent to work. To be successful in this role, you'll need:

• A technical education background, preferably in engineering or a related field.
• Additional qualifications in Quality Management Systems (QSR, ISO 19011, ISO 9001/ISO 13485, Six Sigma) are highly desirable.
• Experience in medical device application and complaint handling, process management, production technology, and familiarity with regulatory requirements in the medical/laboratory equipment sector.
• Proficiency in both German and English, enabling effective communication within our global team and with external stakeholders.
• Strong computer skills, including experience with SAP (Q module/CRM), procurement, quality control, and measurement and testing techniques.

What makes Tecan unique

At Tecan, we offer a dynamic and inclusive work environment that fosters growth and empowers our employees to bring their passion and talent to work. If you're looking for a challenging and rewarding role in a company that shares your values, we encourage you to apply.

Join Tecan

Together, we can make a difference in the world of healthcare and life science. Apply today to become a part of our team and help us shape the future of medical innovation.

Stay unique and make it count.

At Tecan, we are driven to improve people's lives and health. We do this by empowering our customers to scale healthcare innovation globally from life science to the clinic. We collaborate with our customers from early-stage innovation through project implementation and beyond. We deliver the products, services and solutions that make lab processes and medical procedures precise, reproducible and compliant.

Our values - trust, highest standards and ambition - are the cornerstones of our business and provide the framework for Tecan's culture. We foster a positive and empowering environment where our rarest assets, our unique employees, can grow and bring their passion and talent to work.