Description

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, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 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

POSITION SUMMARY

The Manufacturing Quality Engineering Co-op will assist in sustaining and improving the quality processes across the manufacturing workflow to ensure quality product is produced and quality procedures are upheld.

KEY RESPONSIBILITIES

• Participate in the investigation of failures and formulation/implementation of action plans for non-conformances, internal corrective actions, and audit findings.
• Work in cross-functional teams to identify and address non-conformances throughout assembly to final shipment of product.
• Work with engineering teams to ensure quality procedures are followed in all manufacturing and distributing areas.
• Use Lean and Six Sigma tools to analyze non-conformance data and identify opportunities for improvement across Material Review Boards (MRB) and other processes.
• Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
• Assist in the development and maintenance of quality documentation, including investigation reports, correction efforts, CAPAs, and process FMEAs.
• Assist in reviewing process validations and equipment qualifications, including plans, protocols, and reports.
• Utilize software tools to capture non-conformance data to analyze and identify trends for corrective actions or escalations.

REQUIREMENTS

• Undergraduate or grad student pursuing a degree in engineering. Focus on medical devices is preferred
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written)
• Execute tasks in a timely manner without direct supervision. Able to prioritize tasks.
• Proficiency in Microsoft Office Suite.

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.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.