Packaging/Medical Device Quality Specialist
CSL Behring —Bern, BE
- 100%
- Bachelor
- Kommunikationsfähigkeit
6 Tage
Portier - Chauffeur Cat. B, Operations Manager
Alpine Holiday Services GmbH —Wengen, BE
- CHF 4’250 - CHF 4’500 pro Monat
- 100%
- Englisch
- Vor Ort
Direkt bewerben
5 Tage
Quality Assurance Architect Consultant
Vulcain Engineering Group —Bern, BE
- Englisch
- Produktion
13 Tage
Medicine Specialist (Fluent in French) - Freelance AI Trainer Project
Meridial —Bern, BE
- CHF 8 - CHF 65 pro Stunde
- Homeoffice
- Doktorat
- Master
Qualitätsmanagementbeauftragte:r Forschung Neurologie
Insel Gruppe —Bern, BE
- Teilzeit
- Pflege
- Englisch
Consultative Committee Assistant, G4
United Nations —Bern, BE
- CHF 72’731 pro Jahr
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
4 Tage
Assistant, E-Commerce, Physical Services Integration and POC Matters (EPSI), G4
United Nations —Bern, BE
- CHF 36’365.50 pro Jahr
- Teilzeit
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
3 Tage
Scientist Microbiological Quality Control
Thermo Fisher Scientific —Lengnau, BE
- 100%
- Doktorat
- Qualitätskontrolle
- Organisationstalent
Guest Quality Support
Goodtime International Entertainment —Bern, BE
- 100%
- Gastgewerbe
- Kundendienst
- Englisch
Direkt bewerben
Senior Scientist microbiological Quality Control
Thermo Fisher Scientific —Lengnau, BE
- 100%
- Englisch
- Master
2 Tage
Healthcare Specialist (Fluent in French) - Freelance AI Trainer Project
Meridial —Bern, BE
- CHF 8 - CHF 65 pro Stunde
- Homeoffice
- Englisch
- Master
- Patientenversorgung
Science Specialist (Fluent in French) - Freelance AI Trainer Project
Meridial —Bern, BE
- CHF 8 - CHF 65 pro Stunde
- Homeoffice
- Doktorat
- Laborerfahrung
- Master
Head of Quality - Ovomaltine & Caotina (f/m/d) 80-100%
Twinings Ovaltine —Neuenegg, BE
- Hybrides Arbeiten
- Management-Erfahrung
- Englisch
- Mitarbeiterrabatt
Direkt bewerben
Coordinator, Remuneration Governance and Integration, P5
United Nations —Bern, BE
- CHF 103’165 pro Jahr
- Englisch
- Master
- Analysefähigkeit
14 Tage
Project Director, Headquarters Building Renovation, D1
United Nations —Bern, BE
- CHF 117’953 pro Jahr
- Management-Erfahrung
- Englisch
- Master
12 Tage
JUNIOR COMPLIANCE MANAGER
IIC-INTERSPORT International Corporation GmbH —Bern, BE
- Kommunikationsfähigkeit
Pharma-Laborant/in – Qualitätskontrolle
CSL Behring —Bern, BE
- 100%
Quality Assurance Engineer*
HARTING AG —Biel/Bienne, BE
- Englisch
Direkt bewerben
Production Process Operator (m/w/d)
Mondelēz International —Bern, BE
- 100%
- Wartung
LaTex Specialist (Fluent in French) - Freelance AI Trainer Project
Meridial —Bern, BE
- CHF 8 - CHF 65 pro Stunde
- Homeoffice
- Master
- Bachelor

Ich möchte aktuelle Job-E-Mails für Stellen als quality in kanton bern erhalten

Wenn Sie sich bei Ihrem Konto anmelden, stimmen Sie den Nutzungsbedingungen, den Richtlinien zur Verwendung von Cookies sowie der Datenschutzerklärung von SimplyHired zu.

Weitere Job-Standorte erkunden

quality jobs near kanton bern

Packaging/Medical Device Quality Specialist

CSL Behring -
Bern, BE

Jetzt bewerben

Details zur Stelle

100% | Pensum: 90-100%
vor 6 Tagen

Leistungen

Unterkunft

Qualifikationen

R
Bachelor
Verpackung
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Entity: CSL Behring

Job Category: Quality

Job Family: Quality Assurance

Job Type: Full Time

Location: Bern, Berne, Switzerland

Employer Reference: R-275415

Job Description

As part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Combination Product and Medical Device and Packaging QA Associate represents Quality in global teams involved in the design, development, manufacture, and regulatory approval of CSL combination products. These products include medical device constituent parts developed to enable convenience, monitoring, compliance, and effective outcomes for patients.

This role ensures new product development activities for CSL combination product projects follow a 21 CFR Part 4-compliant quality system. The role serves as a subject matter expert on medical device and combination product requirements in accordance with FDA and EU MDR regulations, ISO standards, and industry best practices, with an emphasis on the Design Controls process. The position supports quality-related activities throughout the product lifecycle from concept through industrialization and post-market support, collaborating with multiple global functions and manufacturing sites.

Main Responsibilities and Accountabilities

Serve as Medical Device and Packaging QA Associate on assigned combination product development projects. Work with project leaders and internal/external team members to ensure design and development work meets applicable FDA, EU MDR, and other global regulatory requirements. Ensure design teams follow the Design Controls process and use appropriate quality engineering techniques (e.g., risk analysis, statistical data analysis, sampling plan development). Ensure external medical device development and manufacturing partners meet CSL standards and criteria. Support vendor management activities by participating in audits; reviewing quality and/or development agreements; and monitoring vendor performance. Provide regular progress reports and escalate potential risks related to the Quality System and/or project status to Quality management and stakeholders. Assist with development and implementation of a quality system compliant with 21 CFR Part 4, MDR, and other global requirements. As assigned, propose improvements to existing processes; update SOPs/WIs/Forms; and develop and conduct training on modified processes. Stay abreast of changing regulatory requirements for medical devices and combination products. Maintain systems/databases related to combination products, as assigned (e.g., Applicable Standards List, vendor certificate database, test method validation log). Conduct root cause analysis and problem-solve issues, providing recommendations.

Education

Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a relevant discipline.

Experience

Minimum 3 years of experience as a quality, packaging, engineering, or manufacturing professional in the medical devices or combination products field.
Candidates with pharmaceutical, biotech, MedTech, or other related backgrounds may be considered.

Competencies

Working knowledge of medical device and combination product regulations and requirements, including (at minimum) 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidance, relevant standards, and their application in a compliant QMS.
Minimum 2 years of practical experience in medical devices R&D Quality, including design controls; new product development life cycle; requirements specifications; risk management (including FMEA); verification and validation (V&V); usability/human factors studies; DHFs; and design transfer.
Effective communication and collaboration skills.
Assertiveness.
Problem-solving skills to identify and resolve issues in a timely manner.
Planning and organization skills to prioritize work activities and use time effectively.
Preferred: Experience developing drug-delivery combination products.
Plus: Experience with products that include embedded software, mobile/web apps, and other connected health solutions.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Jetzt bewerben

Erweiterte Suche

quality Jobs in kanton bern

Packaging/Medical Device Quality Specialist

Portier - Chauffeur Cat. B, Operations Manager

Quality Assurance Architect Consultant

Medicine Specialist (Fluent in French) - Freelance AI Trainer Project

Qualitätsmanagementbeauftragte:r Forschung Neurologie

Consultative Committee Assistant, G4

Assistant, E-Commerce, Physical Services Integration and POC Matters (EPSI), G4

Scientist Microbiological Quality Control

Guest Quality Support

Senior Scientist microbiological Quality Control

Healthcare Specialist (Fluent in French) - Freelance AI Trainer Project

Science Specialist (Fluent in French) - Freelance AI Trainer Project

Head of Quality - Ovomaltine & Caotina (f/m/d) 80-100%

Coordinator, Remuneration Governance and Integration, P5

Project Director, Headquarters Building Renovation, D1

JUNIOR COMPLIANCE MANAGER

Pharma-Laborant/in – Qualitätskontrolle

Quality Assurance Engineer*

Production Process Operator (m/w/d)

LaTex Specialist (Fluent in French) - Freelance AI Trainer Project

Ich möchte aktuelle Job-E-Mails für Stellen als quality in kanton bern erhalten

Related Searches