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Sr Quality Systems Engineer I

Date:  Feb 1, 2023
Location: 

Danvers, Massachusetts, US, 01923

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

Job Responsibilities :

 

The Sr Quality Systems Engineer is responsible for supporting the Quality Assurance organization and ensuring compliance of the Quality Management System (QMS). This position is responsible for integrating and maintaining quality management systems and providing quality system support for the Danvers site. This position will be primarily responsible for managing the CAPA program for the entire organization. 

 

Principle Duties and Responsibilities:

 

  • Must have in depth knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
  • Contribute to the development of Quality System performance measures, data collection, trending and reporting.
  • Assures that data obtained during all quality activities is complete, accurate and documented consistently with company policies and procedures.
  • Lead and Manage Corrective and Preventive Action (CAPA) program and improve the CAPA system effciency as necessary.
  • Support and/or lead 3rd party audits, including follow-up on actions. Lead Back Room, communicate and coordinate associated activities across the organization.
  • 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).
  • Establish and support to Abiomed global training program.  
  • Support New Product Development projects, as needed.
  • Other Duties as assigned

Job Qualifications:

  • BS degree in Regulatory Affairs, Clinical Assurance, Life Sciences or related field.  MS preferred.
  • Lead Auditor Certification highly preferred.
  • 5+ years Quality Assurance / Quality Systems experience in an FDA-regulated industry (Medical device).
  • Must be proactive and able to work independently with minimal supervision; strong collaboration skills are essential
  • Knowledge and application of QSR/GMP/GCP/ISO regulations as related to medical device manufacturing.
  • Working knowledge and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Strong analytical and statistical skills
  • Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written)
  • Ability to exercise judgment to determine methods, techniques, and evaluation criteria for obtaining results.
  • Able to work in a fast-paced work environment, prioritize tasks and manage multiple projects at once.

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.


Nearest Major Market: Boston