Quality Management / Regulatory Affairs Specialist (m/f/d)

YOUR TICKET TO MAKE A DIFFERENCE

At Mesa, more than 700 employees combine their technical expertise with technological innovations to improve the quality of life for patients, workers, and consumers all over the world. With products and services that impact the critical environments that drive medical breakthroughs, sustain industries, and ensure the safety of everyday products, our multinational company has a proud history of making a positive impact on global health and safety. We're passionate about using our skills to serve a greater purpose. We approach each day with a unique, customer-focused vision to protect the vulnerable and empower every employee to make a real difference.

Make your difference in Waldems as

QUALITY MANAGEMENT / REGULATORY AFFAIRS SPECIALIST (M/F/D)

The Quality Management / Regulatory Affairs Specialist is responsible for supporting the quality assurance and regulatory affairs processes within the organization. This role involves the evaluation of products and processes to ensure they meet established high quality standards and legal requirements. Assists in the documentation and quality improvement initiatives.

DUTIES/RESPONSIBILITIES:

Creation and Evaluation:

• Collaborate in the establishment, implementation, maintenance and improvement of a quality management system in accordance with national and international standards and regulations.
• Identify defects or issues and work with the development team to ensure resolution.

Documentation and Reporting:

• Assist in the development and maintenance of quality assurance documentation, including standards and procedures.
• Support the development department with the creation and maintenance of development files.

Process Improvement:

• Participate in quality improvement initiatives, error analysis and suggest enhancements.
• Collaborate with team members to identify root causes of quality issues and propose corrective actions.
• Assist in the implementation of best practices for quality assurance.

Compliance and Standards:

• Ensure that all products and processes comply with relevant industry standards and regulations.
• Support internal and external audits and inspections related to quality assurance processes.
• Stay updated on industry trends and standards related to quality assurance.

Collaboration:

• Work closely with cross-functional teams, including development, production, and operations, to ensure quality standards are met.
• Participate in team meetings and contribute to discussions on quality issues and improvements.

Training and Support:

• Provide support and guidance to other staff and new team members.
• Participate in training sessions to enhance knowledge of quality assurance practices and tools.

Regulatory Affairs:

• Involvement in the planning and implementation of approval procedures in Germany and abroad as part of an international team to successfully bring products to market.
• Actively cooperate in the preparation and submission of necessary documents and applications for approval.
• Conduct independent research, prepare and interpret regulatory requirements (incl. relevant laws, regulations and directives).
• Communication with regulatory authorities, notified bodies and business partners in regulatory matters.

EXPERIENCE/EDUCATION:

• Bachelor's degree in Quality Assurance, Engineering, Chemistry, or a related field or be certified as a Technician.
• 0 - 1 year of professional experience.

KNOWLEDGE & SKILLSETS REQUIRED:

• Fluent in English.
• Strong attention to detail, analytical skills, and the ability to interpret quality standards and think strategically.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint) and quality management systems.
• Effective verbal and written communication skills.
• Ability to work collaboratively within a team environment.
• Demonstrated ability to identify issues, analyze data, and propose solutions.
• Prior or initial experience in the medical device or pharmaceutical industry with a quality management system and approval procedures (ISO 13485, MDR, 21 CFR, GMP) is a plus.
• Project Management experience is a plus.
• Willingness to Travel.

This job description is intended to describe the nature and level of work to be performed by employees in this position. It is not intended to be construed as an exhaustive list of all responsibilities and skills required of employees performing this role.

Mesa Labs is proud to be an Equal Opportunity and Affirmative Action employer. We believe in equality for all and celebrate the diversity of our employees, customers, and communities. We believe this increases creativity and innovation, drives business growth, and enables engaged and thriving teams. We are committed to providing an inclusive environment, free from harassment and discrimination, where all employees feel welcomed, valued, and respected.

INTERESTED?

Please apply with your CV and earliest starting date to

hr-mesagermany[AT]mesalabs.com

Die Information über die Verarbeitung Ihrer Daten können Sie Hier finden.

Mesa Germany GmbH | Auf der Lind 10 | 65529 Waldems-Esch | mesalabs.com