Job Detail

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Stellenbeschreibung

What you can expect:

• Serve as a Quality Engineer on assigned combination product development project(s). Work with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA, EU MDR and other global regulatory requirements. Assure that design development teams follow the Design Controls process and utilize appropriate quality engineering techniques such as risk analysis, statistical data analysis, sampling plan development, etc. Serve as a subject matter expert on the medical device / combination product requirements and educate other members of the development team on the internal CP/MD processes


• Utilize Quality Engineering techniques (e.g. Lean Six Sigma methods) to identify and address quality issues related to  CSL Behring’s combination products. Proactively identify potential risks related to Quality System and/or assigned development projects, escalate to Quality management and stakeholders, propose solutions and lead implementation of corrective actions, as appropriate.


• Take an active part in development and implementation of the global quality system for CP/MD complaint with 21 CFR Part 4, EU MDR and other global requirements. As assigned, lead the establishment or improvement of quality processes by identifying applicable regulatory requirements, defining new or proposing improvements to the existing processes, drafting or updating SOPs / WIs / Forms, leading cross-functional review in order to achieve alignment on the proposals, developing and conducting training on the new / modified process(es).


• Actively participate in building internal infrastructure for supporting compliant development and marketing of combination products, such as creating and maintaining database of the suppliers, device constituent parts and their regulatory approval status; modification of existing Product Technical Complaints (PTCs) processes to ensure complaint receipt, investigation and analysis of the device-related issues; development of global inspection readiness program.


• Lead or represent CP/MD QA in other cross-functional initiatives related to combination products, as assigned. Examples may include incorporating combination product requirements into the existing QMS and product development processes (e.g. post market safety reporting, post market surveillance, recalls management, CAPA process, packaging, labeling, etc.)


• Conduct Vendor Management activities applicable to CSL Behring medical device development and manufacturing partners. This includes conducting (or participating in) audits; developing and approving quality and/or development agreements; monitoring vendor performance.


• Proactively monitor changing regulatory requirements for medical device and combination products and recommend changes to the CSL Behring quality system, as necessary to ensure compliance. Provide guidance and education across the broader CSL Behring organization on medical device and combination product requirements


• Collaborate with Affiliate Quality and Commercial colleagues to ensure additional development needs are identified and activities are conducted in accordance with the R&D and life cycle management procedures.


• Assist the Head of Combination Products and Medical Devices Quality with developing, training and mentoring CP/MD Quality staff. May manage junior CP/MD staff, as assigned.

What you bring:

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


• Requires a minimum of 7 years of experience as a quality, engineering or manufacturing professional in medical devices or combination products field. May consider candidates with pharmaceutical, biotech or other related background


• The Lead Quality Engineer should have a strong working knowledge of the medical device and combination product regulations and requirements, at minimum, 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidances, relevant standards and their application in a compliant QMS.


• The Lead Quality Engineer should have an extensive practical experience in medical devices R&D Quality: design controls, new product development life cycle, requirement specifications, risk management (including FMEA), validation / verification (V&V), usability / human factor studies, DHFs, design transfer.