Description

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed’s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

I Am Abiomed | I Am Heart Recovery | Patients First!

The Supplier Quality Engineer II 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 Baltimore Site.

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

· Other duties as assigned by the manager

Qualifications

Job Qualifications:

· Bachelor’s degree required in a related Engineering discipline

· 2+ 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.