QA - RCA Engineer

About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The primary responsibility of this role is to refine the concepts and methodologies of investigation within our organization by provide training to enhance RCA skills among team members to shorten the time required for investigations, improve the performance of investigations. This position will possess a deep understanding of RCA principles, methodologies, and tools, along with excellent communication and leadership skills.

Main Responsibilities

• Develop and deliver training programs on RCA methodologies, tools, and best practices.
• Conduct workshops, seminars, and hands-on training sessions to enhance the RCA skills of investigation Plan owners.
• Monitor the performance of RCA investigations across various projects or departments.
• Analyze investigation outcomes and identify areas for improvement.
• Continuously evaluate and refine RCA processes and methodologies to ensure effectiveness and efficiency.
• Collaborate with cross-functional teams to implement process improvements and standardize RCA practices across the organization.
• Collaborate with various departments to gather relevant data and insights for RCA investigations.
• Communicate findings, recommendations, and action plans to stakeholders iin a clear and concise manner.

Minimum Qualifications

• BS degree above or equivalent technical work experience.
• Clear / logical thinking with strong organization and communication skills
• Proficient problem solving skills.
• Working knowledge of Microsoft Office.

Preferred Qualifications

• Experience in the medical device industry is preferred.
• Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
• CQT (certified quality technician), CQE (certified quality engineer) is a plus.
• Six sigma green belt or black belt is a plus.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.