Quality Assurance Associate

vor 2 Monaten

Berlin, Deutschland Barrington James Vollzeit

Berlin
- 22-05-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- Quality Assurance
- SALARY TYPE
- Annually
- SALARY
- Negotiable

Job Description: Quality Assurance Associate (Berlin, Germany - Medical Devices - Class 2a Sterile Products)

**Company Overview**:
We are a leading medical device company based in Berlin, Germany, specializing in the manufacturing of Class 2a sterile products. Our innovative and high-quality medical devices are designed to improve patient outcomes and enhance healthcare delivery. As we continue to expand our operations, we are seeking a dedicated and detail-oriented Quality Assurance Associate to join our team.

**Position Summary**:
As a Quality Assurance Associate, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality for our Class 2a sterile products. Your primary responsibility will be to support the implementation and maintenance of the quality management system (QMS) in accordance with applicable standards and regulations.

**Responsibilities**:

- Assist in the development, implementation, and maintenance of the QMS for Class 2a sterile products, ensuring compliance with relevant regulatory standards (e.g., ISO 13485, MDR, FDA requirements).
- Conduct internal audits to assess compliance with QMS processes and procedures, identifying areas for improvement and recommending corrective actions.
- Participate in external audits conducted by regulatory authorities or customers, ensuring timely preparation and addressing audit findings.
- Perform document control activities, including the review and approval of quality-related documents such as procedures, work instructions, and validation protocols.
- Support the management of non-conformities and CAPA (Corrective and Preventive Actions) processes, investigating deviations and implementing appropriate corrective actions to prevent recurrence.
- Assist in the review and approval of product change notifications, ensuring that changes are appropriately assessed and validated to maintain product quality and regulatory compliance.
- Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to provide quality-related guidance and support throughout the product lifecycle.
- Monitor and analyze quality data, such as complaints, deviations, and trending, to identify potential quality issues and drive continuous improvement initiatives.
- Stay updated with relevant regulatory requirements, industry trends, and best practices in quality management for medical devices.

**Qualifications**:

- Bachelor's degree in a scientific or engineering discipline (e.g., Biology, Biomedical Engineering, Quality Management) or a related field.
- Previous experience (2-3 years) in a quality assurance role within the medical device industry, preferably with exposure to Class 2a sterile products.
- Strong knowledge of quality management systems, standards, and regulations applicable to medical devices (e.g., ISO 13485, MDR, FDA requirements).
- Experience with conducting internal and external audits, including audit preparation, execution, and follow-up activities.
- Proficient in document control processes and systems.
- Excellent attention to detail and strong analytical skills.
- Effective communication and interpersonal skills, with the ability to collaborate and influence cross-functional teams.
- Self-motivated and able to work independently as well as in a team environment.
- Fluency in English (both written and spoken); knowledge of German would be advantageous.

We offer a competitive salary package and a stimulating work environment where you can contribute to the development and production of life-saving medical devices. If you are passionate about quality assurance and have a strong commitment to ensuring patient safety, we invite you to for the position of Quality Assurance Associate with our company.

Consultant
- Tomas Swithenbank
- +441293776644

  • Quality Assurance Associate

    vor 2 Wochen

    Berlin, Deutschland Talent Source Vollzeit

    Description: **Location**:Germany, Berlin - Hybrid **Schedule**:Full Time, Permanent Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds. TalentSource Life Sciences (the sponsor-dedicated...

  • Associate Director Quality Assurance

    vor 1 Monat

    Berlin, Deutschland KCR Vollzeit

    **We see human behind every number** **Associate Director, Quality Assurance** **Location: Germany, UK or Poland (office-based/hybrid)** At this position you will be responsible for organization of KCR strategies in the scope of Quality Assurance and providing direct compliance and support to all areas of operations of KCR within CEE region. You will...

  • Quality Assurance Representative

    vor 2 Wochen

    Berlin, Deutschland Amentum Vollzeit

    **Quality Assurance Representative**: - R0079206 - Berlin, Germany - Full time - Add to favorites Favorited View favorites **Supporting the Most Exciting and Meaningful Missions in the World** Quality Assurance RepresentativeQAR: light to heavy wheel vehicle surveillance inspections at SOR sites, ensuring equipment is repaired IAW TMs, MWOs, etc.;...

  • Quality Assurance Lead

    vor 1 Monat

    Berlin, Deutschland Smartly.io Job Board Vollzeit

    We are looking for a Quality Assurance Lead to help us reach the next level in our reliability journey. Your task, if you choose to accept it, will be owning our QA strategy and seeing it become alive in close cooperation with our Product Development teams. As you are the first person in this function and take ownership in the area, you won't be coordinating...

  • Working Student in Quality Assurance

    Vor 2 Tagen

    Berlin, Deutschland Vanilla Steel Vollzeit

    Vanilla Steel is a digital B2B platform serving the European metal industry with data and innovation with the mission of simplifying how steel and other metals are traded today. We are a team of passionate tech entrepreneurs that combine more than 50 years of digital experiences with a passion for solving existing challenges through digitization. We are...

  • Quality Assurance Representative

    vor 2 Wochen

    Berlin, Deutschland Amentum Vollzeit

    **Quality Assurance Representative (PQASIS)**: - R0095423 - Berlin, Germany - Full time - Add to favorites Favorited View favorites Quality Assurance Representative QAR: light to heavy wheel vehicle surveillance inspections at SOR sites, ensuring equipment is repaired IAW TMs, MWOs, etc.; verification of quality of work. must have experience as a...

  • Quality Assurance Representative

    vor 5 Stunden

    Berlin, Deutschland Amentum Vollzeit

    **Quality Assurance Representative (PQASIS)**: - R0099880 - Berlin, Germany - Full time - Add to favorites Favorited View favorites Quality Assurance Representative QAR: light to heavy wheel vehicle surveillance inspections at SOR sites, ensuring equipment is repaired IAW TMs, MWOs, etc.; verification of quality of work. must have experience as a...

  • Quality Assurance Specialist

    Vor 3 Tagen

    Berlin, Deutschland Lieferando Vollzeit

    **Quality Assurance Specialist** Want to support the development of key payroll products at the heart of a major international food delivery business? Enjoy working in a challenging agile environment? Then keep reading **Our story** As a growing business, we're searching for opportunities to perfect our processes and implement methodologies that help our...

  • Quality Assurance Specialist

    vor 2 Monaten

    Berlin, Deutschland Experis GmbH Vollzeit

    Quality Assurance Specialist (gn) **Bereit für eine neue Herausforderung?**: Für unseren renommierten Kunden in der IT suchen wir Sie im Rahmen der Direktvermittlung als **Quality Assurance Specialist(gn)** am Standort Berlin. Finden Sie mit **Experis **den richtigen **Job**! Nutzen Sie unsere Erfahrung und Beratung für Ihre bestmögliche Entwicklung....

  • Quality Assurance Representative

    Vor 2 Tagen

    Berlin, Deutschland Amentum Vollzeit

    **Supporting the Most Exciting and Meaningful Missions in the World** Quality Assurance Representative QAR: light to heavy wheel vehicle surveillance inspections at SOR sites, ensuring equipment is repaired IAW TMs, MWOs, etc.; verification of quality of work. Amentum is proud to be an Equal Opportunity Employer. Our hiring practices provide equal...

  • Customer Service

    vor 2 Monaten

    Berlin, Deutschland ON RUNNING Vollzeit

    Land **:Deutschland** Bundesland **:Berlin** Stadt **:BERLIN** Berufsfelder **:Handel** Vertragsform **:Festanstellung** Arbeitszeit **:Vollzeit** **Stellenbeschreibung**: In short Our Europe happiness delivery team is growing, just like On, and with this comes the exciting opportunity to become a Happiness Deliverer Quality Assurance Lead. We are...

  • Customer Service

    Vor 2 Tagen

    Berlin, Deutschland ON RUNNING Vollzeit

    Land **:Deutschland** Bundesland **:Berlin** Stadt **:BERLIN** Berufsfelder **:Handel** Vertragsform **:Festanstellung** Arbeitszeit **:Vollzeit** **Stellenbeschreibung**: In short Our Europe happiness delivery team is growing, just like On, and with this comes the exciting opportunity to become a Happiness Deliverer Quality Assurance Lead. We are...

  • Senior Quality Assurance

    vor 1 Monat

    Berlin, Deutschland Lieferando Vollzeit

    We are looking for a Quality Assurance Specialist to join the Curiosity Team in the Logistics Department and increase our QA workforce. **As our QA expert, you**: - Plan and execute tests on specific areas according to project features and milestones - Design, create, implement and maintain test cases, test scenarios - Deliver feedback and reports to the...

  • Test & Quality Assurance

    vor 1 Monat

    Kreisfreie Stadt Berlin, Deutschland Octagon Vollzeit

    Function description and tasks Successful assessment and validation of business requirements for quality management system (QMS) software solutionsEstablishment of harmonised quality assurance processes and procedures for the development and implementation of global QMS software solutions Development and implementation of comprehensive test strategies and...

  • Test & Quality Assurance

    vor 1 Woche

    Kreisfreie Stadt Berlin, Deutschland Octagon Vollzeit

    Function description and tasks Successful assessment and validation of business requirements for quality management system (QMS) software solutionsEstablishment of harmonised quality assurance processes and procedures for the development and implementation of global QMS software solutions Development and implementation of comprehensive test strategies and...

  • Working Student

    vor 3 Wochen

    Berlin, Deutschland sonnen GmbH Vollzeit

    Standort: Berlin, BE, DE- Stellen-ID: 4234**At the earliest date possible we are looking for support for our #teamsonnen**: Clean and affordable energy for all is one of the greatest challenges of our time. Sonnen has been committed to this mission since 2010 and is now represented in Europe, the USA and Australia with over 1,000 team members globally. In...

  • Werkstudent:in Manual Tester

    Vor 3 Tagen

    Berlin, Deutschland Software & Support Media GmbH Vollzeit

    Für unser Berliner Team suchen wir eine/n Werkstudentin/Werkstudenten als **Manual Tester - Quality Assurance.** **Dein vielfältiges Aufgabengebiet** - Durchführung manueller Tests auf unseren Plattformen entwickler.deund devmio (mobile App und Web-App) zur Sicherung der Funktionalität, Benutzerfreundlichkeit und Performance - Identifizierung, Erfassung...

  • Quality Management and Assurance for Adas

    vor 2 Monaten

    Berlin, Deutschland CARIAD SE Vollzeit

    Quality Management and Assurance for ADAS Functions/ Components (M/F/d) **Project - & Product Management** **Professional** - Berlin, Wolfsburg, Ingolstadt, Mönsheim/Stuttgart, Munich We are CARIAD, an automotive software company and part of the Volkswagen Group. Our mission is to make the automotive experience safer, more sustainable, more comfortable,...

  • Werkstudent Supplier Quality Assurance

    Vor 2 Tagen

    Berlin, Deutschland ZEISS Group Vollzeit

    Ihre Rolle- Wareneingangsprüfungen im Labor der Supplier Quality Assurance durchführen- Labortätigkeiten wie z.B. UV-VIS-, FT-IR-, Osmolarität-, Brechungsindex-, Löslichkeitstest - sowie pH-Messungen vornehmen- Lieferantendokumente/-Zertifikate prüfen und mit Spezifikationsvorgaben abgleichen- Datenauswertungen in Excel erstellen- Arbeitsanweisungen...

  • Junior Quality Assurance Manager

    vor 3 Wochen

    Berlin, Deutschland Sunday Vollzeit

    Your roleJoin our team at Sunday Natural and contribute to ensuring the highest quality standards for our products. As our Junior Quality Assurance Manager, you'll play a crucial role in maintaining our commitment to excellence and continuous improvement in product testing and quality control processes.Establish and maintain effective communication channels...