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Senior Quality Systems Engineer (m/f/d)

Datum:  27.11.2022
Standort: 

Aachen, NW, Deutschland

Abiomed is an innovative medical device company with an inspiring mission "Patients first." and a unique guiding company principle "Regenerating hearts. Saving lives." With 2,000 employees, Abiomed is one of the fastest growing medical technology companies in the world with corporate headquarters in Danvers, USA and locations in Aachen and Berlin, Germany, Tokyo, Japan and Singapore.

Abiomed is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

Reporting to the Sr Manager of Global Quality Systems, The Sr. Quality Systems Engineer I is responsible for helping and supporting the Quality Systems organization from Abiomed GmBH location by ensuring compliance of the Global Quality Management System (QMS) with applicable Medical Device standards and regulations.

 

Principle Duties and Responsibilities:

 

  • Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system.
  • Oversee the company’s Internal Audit system, including tracking and follow-up on all audit findings.
  • Support and/or lead 3rd party audits, including follow-up on actions.
  • Partner with Process owners to generate and metrics, which reflect the health of different Quality System elements.
  • Support Internal Audit program, e.g., participate/lead Internal audits, follow up on the finding with auditee through effective closure, present the data for trending, etc.
  • Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
  • Support New Product Development projects, as needed.

 

Job Qualifications:

 

  • Bachelors degree required. MS preferred.
  • Several years Quality Assurance / Quality Systems experience in an FDA-regulated industry (medical device, pharmaceutical).
  • Knowledge and application of QSR/GMP/GCP/ISO regulations as related medical devices manufacturing.
  • Working knowledge and practical application of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971.
  • Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written), demonstrating strong analytical and statistical skills
  • Ability to exercise judgment to determine methods, techniques and evaluation criteria for obtaining results.
  • Able to prioritize tasks and manage multiple projects at once. 
  • SAP experience (Quality Module, DMS) a plus.

We offer:

 

  • Pleasant, open corporate culture with a strong mission: "Recovering Hearts, Saving Lives"
  • Comprehensive induction program with structured onboarding plan throughout the orientation phase
  • Company pension allowance of up to 1,500 euros per year and capital-forming benefits
  • Abiomed shares at a preferential price
  • Benefit packages for occupational disability insurance and company group accident insurance
  • Full cost coverage for a job ticket in the Aachen or Berlin area
  • Various health programs and a leasing option for a job bike

 

ABIOMED is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin.