Senior Quality Engineer Combination Products based in Bern or Marburg
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
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1500 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide. For our location in Bern, we are looking for a Senior Quality Engineer Combination Products JOB PURPOSE:
The successful candidate will support design, development, manufacture and regulatory approval of CSL Behring combination products, which include medical device constituent parts developed to enable convenience, monitoring, compliance and effective outcomes for the lives of our patients.
This role is responsible for ensuring that new product development activities for all CSL Behring combination product projects follow a 21 CFR Part 4 compliant quality system. The successful candidate will serve as a subject matter expert on medical device and combination product requirements in accordance with FDA / EU MDR / ISO regulations, standards and industry best practices with the emphasis on Design Control process. This role will be involved in the quality related activities throughout entire product lifecycle from product concept through industrialization and post market support.
The successful candidate will collaborate with the multiple global functions and manufacturing sites. RESPONSIBILITIES:
Serve as Quality Engineer on assigned combination product development projects. Work with project leaders and both internal and external team members to ensure that all design development work meets applicable FDA and ISO QMS 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.
Provide regular progress reports and escalate potential risks related to Quality System and/or project status to Quality management and stakeholders.
Lead Vendor Management activities applicable to CSL Behring medical device development and manufacturing partners. This will include conducting (or participating in) the audits; developing and approving quality or development agreements; monitoring vendor performance.
Assist with development and implementation of the quality system complaint with 21 CFR Part 4, EU MDR and other global requirements. As assigned, identify applicable regulatory requirements, define new or propose improvements to the existing processes, draft or update SOPs / WIs / Forms, develop and conduct training on the new / modified processes.
Stay abreast of changing regulatory requirements for medical device and combination products and proactively recommend changes to the CSL Behring quality system, as necessary to ensure compliance.
Lead / participate in other cross-functional initiatives related to the combination products, as assigned. Examples may include incorporating combination product requirements into the existing company-wide QMS processes (e.g. post market safety reporting, post market surveillance, recalls management, CAPA process, etc.)
EDUCATION: Bachelor's degree in mechanical or biomedical engineering, life sciences or relevant discipline.
EXPERIENCE: Requires a minimum of 5 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. COMPETENCIES:
Candidate 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 MDD / MDR, relevant FDA guidances, relevant standards and their application in a compliant QMS.
Candidate 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, DMRs.
This role requires effective communication and collaboration skills, including ability to interact with all levels of management. Candidate should demonstrate managerial courage by stepping up to address difficult issues and saying what needs to be said.
Candidate should demonstrate the ability to coordinate multi-functional activities in a highly regulated environment resulting in concrete business results.
This role requires demonstrate problem-solving skills to allow identifying and resolving problems in a timely manner.
This role requires planning / organization skills to allow prioritizing work activities and using time effectively. Strong ability to multitask is required.
Experience in the development or oversight of quality systems is highly desirable.
Quality system auditing (internal and vendor audits) experience is highly desirable. ISO 13485 Auditor certification or similar is a plus.
Experience with developing medical devices or combination products that include embedded software, mobile / web apps and other connected health solutions is a plus.
WORKING CONDITIONS: No special requirements.
TRAVEL REQUIREMENTS: This role requires periodic domestic and international travel.
We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.
CSL Behring is committed to provide equal employment opportunity for all.