Quality Engineer - Product Investigation

Posted 3 Days Ago
Be an Early Applicant
Valencia, Comunidad Valenciana
Entry level
Healthtech • Pharmaceutical
The Role
The Quality Engineer conducts investigations on complaint products, coordinates testing, prepares documentation, and ensures compliance with FDA and ISO guidelines.
Summary Generated by Built In

Perform quality investigation on complaint products as part of the Post-market Surveillance team

Plan and implement technical laboratory experiments/returned product evaluations, which may include providing feedback and suggestions based on experimental results. Contribute to the experimental planning process and advance research/manufacturing process.

This is a temporary contract of 8 months.
 

How you’ll make an impact:

Coordinate and conduct independent investigational testing/analysis, including data collection and analysis under supervision
o May write and execute protocols
o May acquire images by using the Digital Microscope System if needed
o Participate in special projects related to evaluation of existing and developmental products and processes
o Prepare and document laboratory data in accordance with FDA, ISO (Internal Standards Organization), and in-house guidelines.
o Prepare technical findings reports, summaries, protocols, and quantitative analysis. Observe and draw conclusions regarding testing performed. Maintain accurate and complete records, methods, measurement and observations related to assigned projects/evaluations.
• Monitor, collect, and analyze results from routine samples/test methods per established procedures and/or protocols
• Other incidental duties assigned by Leadership
 

What you’ll need:

Bachelor's Degree in in Engineering or Scientific field Required
Experience working in a medical device, pharmaceutical industry and/or lab environment Preferred
 

What else we look for:

• Good computer skills in usage of MS Office Suite
• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills
• Good understanding and knowledge of principles, theories, and concepts relevant to a laboratory environment
• Good problem-solving, organizational, analytical and critical thinking skills
• Good understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to medical device manufacturing
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including immediate supervisor and other team members in the section or group; and may interact with vendors
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

What is  it  like  to work at  Edwards  Lifesciences  in  Spain?

As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).  

Edwards  Lifesciences  in  Spain  also  offers  the  following  benefits:

  • Competitive  Compensation  and  Benefits  package
  • Flexible  working  hours,  remote  working
  • Pension  plan
  • Life  Insurance
  • Medical plan
  • Meal  Vouchers  
  • Service  Awards
  • Enhanced  Leave  benefits
  • Employee  Stock  Purchase  Programme
  • Employee  Assistance  Programme
  • ComprehensiveWellness  programme  including  gym  membership  reimbursement,  fresh  fruit  in  theoffice,  yoga  lessons,  subsidized  massages,  mindfulness  sessions,  educational events,  charity  activities and  much more.

Benefits  are  regulated  by  an  internal policy  which  contains  the  full details regarding  the entitlement and  conditions  for  the  benefits.  Benefits  policy and  components  may  vary  by  location. 

Top Skills

Ms Office Suite
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The Company
Draper, Utah
13,687 Employees
On-site Workplace
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.

Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.

Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.

Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.

For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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