Pharmacist, Biotechnologist as Quality Engineer - Laboratory (m/f/d)

Beschreibung

Quality Engineer II (m/f/d)

PENZBERG, GERMANY

Foundation Medicine dedicated to transforming the way in which patients with cancer are diagnosed and treated. At Foundation Medicine you will work with everyone fighting the disease-patients and their families, payers, physicians, drug developers-to raise awareness about the ongoing evolution in cancer care and to ensure we are delivering the analytic tools and molecular information required to bring the promise of personalized cancer care into routine clinical practice. As a member of our International Laboratory Operations Team, you will be responsible for distilling the latest advances in genomic science, technology and clinical data into innovative, best-in-class clinical diagnostic tools and data products that will enable oncologists to determine the best treatment throughout each patient’s journey with cancer.

Your Team

FMI Germany GmbH in Penzberg, Germany is seeking a Quality Engineer II. As part of the lab operations quality team you will be supporting day to day quality management laboratory activities that provides the insights that directly help the doctors match patients to more treatment options. Within the quality systems team this role will partner with all parts of the organization ensuring that the FMI Quality Management System is dynamic, effective, and compliant creating a competitive advantage for FMI. This position supports the planning and work of multiple project teams with a big picture mindset. This role will present the incumbent with an opportunity to work with various teams within FMI. The role is based within the Foundation Medicine GmbH Team in Penzberg, which currently consists of approx. 70 employees in various roles. We continue to maintain our startup mentality and strong team spirit, which is reflected in short decision paths, mutual support, and high levels of trust. For over three years, we here in Penzberg have been making a genuine contribution to the lives of many patients around the world-to ensure we can continue to do so, we need you in our team!Key Responsibilities

• Participate in the development and approval of quality system procedures, and laboratory documentation and controls.
• Subject matter expert for audit-related questions within the related area including front room and back-room support and management for audits by Accreditation or Notified Bodies, or pharma partners or as part of supplier management.
• Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, international and national regulations and are aligned with regulatory agency expectations.
• Effectively collaborate with a fully integrated team to facilitate the completion of documents.
• Maintain Quality Management Systems for functional area including Change Management and Non-Conformance Reports.
• Conduct root cause analysis, risk analysis and implementation of correction, corrective and preventative actions (CAPA) and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
• Management of equipment qualifications and process/method validations
• Other duties as required.

Your qualifications

• Bachelor’s degree with at least 5 years of experience in the pharmaceutical, biotechnology, medical device, or diagnostic industries, in a QA function or equivalent or Master`s degree with at least 3 years of experience
• Knowledge of requirements in a regulated environment, ideally GCLP, ISO 15189, ISO 13485, ISO 17025 and/or IVD-D/IVD-R
• Working experience with electronic documentation (eDMS, SharePoint) and electronic quality management systems (eQMS), like Veeva or Cornerstone.
• Must be detail oriented with excellent prioritization and organizational skills
• Must have experience and passion for documentation management
• Must be able to deliver results on schedule in a fast-paced, dynamic environment
• Experience in the diagnostics industry strongly desired
• High level MS office skills, including SharePoint
• Excellent attention to detail and multitasking skills
• Fluency in spoken and written German and English.

Development opportunities and benefits

• You can expect a high degree of independence and a flexible working environment
• (work from home/office)
• We stand for sincere and trust-based interaction with each other
• Your personal and professional development is very important to us
• All the advantages of a familiar work environment while being embedded in a large, global company