Head, Person, Laboratory, Face, Scientist, Computer Hardware, Electronics, Hardware, Monitor, Screen

취업 지원자를 위한 중요 알림!
Bio-Rad는 지원자로부터 정보를 얻기 위해 Bio-Rad 채용 담당자로 가장한 개인에 대한 보고를 받았습니다. Bio-Rad는 이러한 채용 관행을 엄격하게 준수한다는 점에 유의하십시오.

Quality System Specialist - fixed term

  • 2024-35424
  • Budapest, Hungary
  • Quality & Regulatory
  • 잡종

The new Quality System Speciliast colleague will be part of the Global Quality System organization and their main responsibility is focused on global post market follow up activities. In this role, the colleague will have daily responsibilities for: managing and assuring PMPF deliverables are completed on a timely manner (e.g. scientific literature review, post market clinical studies, marketing evaluations, clinical and published experience gained, as well as assessment of product benefit risk and overall report conclusion). As part of the global post market surveillance reporting team, the candidate will be planning, scheduling, analyzing resource allocation and coordinating cross functional meetings and serving as liaison between PMPF and PSUR Team members while resolving any quality issue that may arise. This includes regular interactions with area subject mater experts to ensure data is collected, documented and analyzed in a timely and accurate manner.

 

Please note that this is a fixed-term position for 12 months.

 

How You’ll make an impact:

  • Harmonization of PMPF process and assures tasks are carried out by overseeing the generation and
  • scheduling of Post Market Performance Follow up reports
  • Coordinates and executes PMPF activities among cross-functional teams (R&D, Clinical Affairs, Marketing,
  • RA/QA) in order to obtain deliverables
  • Guarantee all PMPF deliverables are prioritized, executed and aligned according to the PSUR Report
  • Responsible for coordination of PMPF Plans revisions and PER, as needed.
  • Evaluates the needs of team members and escalates high risk issues to management representative as needed.
  • Highly organized and manage multiple assignments effectively; organize and prioritize workload; work well under pressure; problem solving
  • Facilitate cross functional requirements from global business partners
  • Coordinate post market performance follow up report activities to ensure completion of periodic reports
  • Work with business partners to identify and escalate product performance issues and recommend actions as appropriate
  • Ensure reports comply with internal QMS and ISO 13485 and EU IVDR requirements
  • Assure alignment with PMPF and PSUR Reporting processes are met

     

 

What You'll bring:

 

  • Education: BS in science related field (Biology, Chemistry or Pharmaceutical) or ideally 5 years’ experience working in a
  • Quality / Regulatory / Project Management field
  • Work Experience: minimum of 3 years managing projects or in administrator role, familiar with IVDR post
  • Marketing regulation is preferred
  • Advance English level: Able to communicate effectively in English verbally and written as well
  • Ability to prioritize and meet deadlines
  • Strong analytical and writing skills
  • Proficient use of Microsoft applications: Word, Excel, Power Point, OneDrive, SharePoint, Teams

 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.    

  

Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer a variety of options, including:  

  

  • Life and accident insurance,  
  • Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge  
  • Competitive salary and cafeteria  
  • 100% commuting allowance for non Budapest residents  
  • Annual bonus  
  • Annual salary review  
  • Marriage and childbirth allowance  
  • School start allowance  
  • All You Can Move contract possibility/gym facility discount  
  • Hybrid working model (3 days onsite and 2 days home office. Our office is located in Budapest, Futó u. 47, 1082) 

 

#LI-Hybrid

 

 

 

다른 사람들이 본

Quality Control Tech II 필수(현장) 3 - Mid-Level 2024-35465 Santa Rosa California United States Santa Rosa, California, United States Quality & Regulatory The Quality Control Technician will support the Quality Control department during the manufacture and release of Bio-Rad injection molded products. As a Quality Control Technician, you will be responsible for ensuring that all products meet the re...
Production Warehouse Supervisor III 필수(현장) 3 - Mid-Level 2024-35501 Richmond California United States Richmond, California, United States Manufacturing/Production Bio-Rad is looking for a Warehouse Supervisor for the Richmond, CA, Chemical Plant to manage onsite hazardous material and non-hazardous material warehouses, offsite warehouse requests, hazardous and non-hazardous waste storage, refrigerated space...
Warehouse Associate I 필수(현장) 2 - Entry Level 2024-35461 Woodinville Washington United States Woodinville, Washington, United States As the Bio-Rad Warehouse Associate I, you will be involved in any number of material handling activities to include:  receiving, order picking, staging, cycle counting, and delighting our customers.  You will work in a team oriented environment fr...
Cash Collection Analyst - French Speaking 잡종 3 - Mid-Level 2024-35487 Budapest Hungary Budapest, Hungary Finance The role is working collaboratively with the EMEA Collections Team to develop and sustain business practices and/or procedures for all related processes and data related to Customer Collections and Dispute Management. The individual will also work...
Cash Collection Analyst - Italian Speaking 잡종 3 - Mid-Level 2024-35488 Budapest Hungary Budapest, Hungary Finance The role is working collaboratively with the EMEA Collections Team to develop and sustain business practices and/or procedures for all related processes and data related to Customer Collections and Dispute Management. The individual will also work...
Field Service Eng 잡종 3 - Mid-Level 2024-35470 Rishon Le Zion Israel Rishon Le Zion, Israel 영업 및 마케팅 Job Responsibilities: Perform field service activities, including on-site installation, upgrades, preventive maintenance, and system repairs. Solve a wide range of hardware and/or software problems of varying complexity. Coordinate work schedule...

지금 신청하세요

이와 같은 채용 정보에 대해 알려주세요.

너 말고?

감사합니다

바이오라드 소개

Bio-Rad에 대해 자세히 알아보세요.

4_review_stars.png

“꾸준한 성장과 탄탄한 실적”

그룹 리더 - 테스트 엔지니어링(현 직원) Hercules, CA

"예의바르고 존중하는 사람들이 모인 가족친화적인 회사..."

Didn’t find the job you were looking for?

Join our talent network! Receive job alerts, quarterly newsletters and other helpful information from Bio-Rad. You may opt out at any time.

너 말고?

감사합니다