Packaging/Medical Device Quality Specialist — CSL Behring
NewCHF 49'500 - 75'000
CSL Behring · Bern (BE)
- Location
- Bern
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 49'500 - 75'000
Role overview
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.
- 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.
- Main Responsibilities and Accountabilities
- Serve as Medical Device and Packaging QA Associate on assigned combination product development projects.
Main responsibilities
- 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.
Application process
- 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.
Company and context
- Planning and organization skills to prioritize work activities and use time effectively. Preferred
- Plus: Experience with products that include embedded software, mobile/web apps, and other connected health solutions. About CSL Behring CSL Behring is a global biothera
Additional details
- Conduct root cause analysis and problem-solve issues, providing recommendations.
- Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a relevant discipline.
- Candidates with pharmaceutical, biotech, MedTech, or other related backgrounds may be considered.
- Plus: Experience with products that include embedded software, mobile/web apps, and other connected health solutions. CSL Behring is a global biothera
Notes and original content
- Experience
- Competencies
- Planning and organization skills to prioritize work activities and use time effectively.
- Plus: Experience with products that include embedded software, mobile/web apps, and other connected health solutions.
- About CSL Behring
- CSL Behring is a global biothera
