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Senior Quality Assurance Engineer (Change Control & Complaints) @ MER

CHOnsiteFull-time
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About this role

About Merz Aesthetics

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient's needs with high standards of safety and efficacy. Being family owned for more than 115 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics' global headquarters is in Raleigh, N.C., USA, with a commercial presence in 90 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany. Learn more at merzaesthetics.com.

Position Snapshot

Job Title: Senior Quality Assurance Engineer Location: Lonay (Vaud, Switzerland) Activity rate: 100% Type of contract: CDI

Key Responsibilities

Lead and coordinate the Change Control process, ensuring appropriate assessments, approvals, implementation, training, compliance, and effectiveness monitoring. Review and approve product complaints, support investigations, monitor trends and quality signals, and contribute to risk management activities based on post-market surveillance data. Support internal, external, and regulatory audits and inspections, drive quality improvement initiatives, manage deviations, non-conformances and CAPAs within scope, and ensure compliance with applicable medical device and pharmaceutical regulations. Utilize approved digital and AI-enabled tools to support analysis, reporting, documentation, and continuous improvement activities.

What will make you successful

Knowledge & Skills

• Knowledge of quality and regulatory requirements applicable to medical devices and/or pharmaceutical products, including ISO 13485, ISO 14971, FDA Quality System Regulations, GMPs, and applicable international regulations

• Strong analytical, problem-solving, and risk-based decision-making skills

• Ability to work independently, take ownership of activities, manage multiple priorities, and identify improvement opportunities

• Strong attention to detail, accuracy, rigor, and organizational skills

• Strong communication and presentation skills

• Strong collaboration and stakeholder management skills across functions, sites, and multicultural environments

• Proficiency in Microsoft Office applications, Quality Management Systems, and digital and AI-enabled tools

• Fluent in English

• Fluent in French (preferred)

Education & Qualifications

Master of Science (M.S. or M.Sc.) in medicine, pharmacy, engineering, quality, or another relevant scientific discipline.

Professional Experience

At least 7 years of professional experience, including a minimum of 5 years in Quality within the Medical Device or Pharmaceutical industry.

What we offer

Work-life balance: Our time is precious; to promote a good work-life integration, we allow flexible working hours and home office work, depending on the position requirements. Our employees also benefit from generous annual leave arrangements.

Ongoing training: Your personal and professional development is key to our success. You will have access to multiple training programs (e.g., LinkedIn Learning, FranklinCovey, Harvard online) and development opportunities.

Benefits: We offer various benefits, such as premium accident insurance, attractive Pension Fund, discounts programs, Employee Assistance Program, and regular fun team activities.

Sustainable development: The Merz Group is investing at every site to achieve carbon neutrality by 2035.

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