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Sr. Supplier Quality Engineer

Date:  Aug 11, 2022
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
 

The Sr. Supplier Quality Engineer is responsible for cross-functional Quality Assurance, Quality Management/Compliance and activities associated with all Abiomed products and processes with a focus on supplier for the Danvers plant.

 

Primary Duties and Responsibilities:

 

  • Provide quality engineering support in the development and manufacturing of new and existing disposable medical devices.
  • Lead Auditor for all external supplier audits and ensure audit schedule is developed and followed
  • Lead analysis of defective components found in Incoming Inspection and work with suppliers to resolve (SCARs)
  • Lead/support the supplier evaluation process when selecting & qualifying new suppliers; help maintain the ASL, supplier scorecards, and supporting documentation required per SOPs
  • Resolve incoming inspection yield issues by driving tighter vendor process capabilities and ensuring appropriate internal drawing tolerances
  • Ensure compliance of manufacturing processes and areas to all applicable quality system regulations
  • Monitor and analyze production information to support risk management and to provide direction for corrective and preventive actions and/or process improvement activities (CAPA)
  • Validate manufacturing and supplier processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
  • Work with manufacturing engineering and supply chain to ensure necessary process controls and validations are in place and best practices are followed (GMP)
  • Identify key process input variables and key process output variables
  • Support Quality Management System (process development, creating and editing new and existing SOPs). Support internal auditing requirements in manufacturing

 

 

Job Qualifications:

 

  • Bachelor’s degree required in a related Engineering discipline
  • 5+ years of experience in QA/QE in the medical device field
  • Experience with manufacturing of complex products in an ECA, ideally catheter-based or cardiac assist devices is preferred
  • Manufacturing and supplier quality control experience
  • Experience with formal problem-solving methodologies and deductive skills
  • Good understanding of FDA QSRs, ISO13485, Ordinance 169, ISO14971
  • Experience with handling non-conforming material and assemblies; including root cause investigations pertaining to such non-conformities
  • Experienced in qualification of production equipment and verification of production processes
  • Experience performing internal and supplier audits of manufacturing processes
  • Utilized statistical data analysis for trending purposes; ideally utilized Six Sigma methods and tools
  • Experience with SAP or other ERP system is a plus
  • Willingness to travel, particularly to visit suppliers (10% required)

 

 

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