Job Description:

At Abiomed, part of Johnson & Johnson, we are currently seeking a highly skilled and motivated individual to join our team as a Sr. Manufacturing Quality Engineer to support our facilities expansion. In this role, you will have the unique opportunity to contribute to manufacturing of life-saving medical devices. As part of our "Patients First!" culture, you will play a crucial role in ensuring the highest quality standards are met to save lives and recover hearts.

The anticipated annual base pay range for this position is 75,000 - 118,450 Euro.

Responsibilities and Duties:

• Provide quality engineering support in the development and manufacturing of new and existing equipment and facilities

• Ensure compliance of manufacturing processes and areas to all applicable quality system regulations

• Lead Quality reporting such as, key performance metrics, goals, and objectives for capital products

• Lead and support activities related to the Material Review Board for facilities

• Lead non-conformance investigations, including cause analysis, documenting findings, and approving material dispositions. Promptly address any quality concerns through corrections, corrective/preventative actions, and Escalations for any facility and environmental non conformances.

• Monitor and analyze production information to support risk management and provide direction for corrective and preventive actions (CAPA) and/or process improvement activities for facilities

• Validate manufacturing processes, including activities associated with equipment installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), Test method validations (TMV) for facility expansion

• Collaborate with manufacturing engineering to ensure the implementation of necessary process controls and validations, while adhering to established guidelines (GMP)

• Support process optimization using design of experiments (DOE) and retrospective data analysis to understand and minimize sources of process variation affecting products. 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 and external auditing requirements in manufacturing for capital products

Qualifications:

• A Bachelor's degree in a relevant Engineering field is necessary

• 6+ years of experience in QA/QE in the medical device field.

• Experience with facility moves and implementation of new equipment in facilities.

• Experience with formal problem-solving methodologies and deductive skills.

• Good understanding of FDA QSRs, ISO13485, ISO14971.

• Experience with handling non-conforming material and assemblies, including root cause investigations.

• Experienced in qualification of production equipment and validation of production processes.

About Johnson & Johnson:

Johnson & Johnson is a globally renowned company dedicated to improving the health and well-being of people around the world. As a leader in the medical technology industry, we are committed to developing and delivering world-class medical devices that save lives and enhance patient outcomes. Our company culture is rooted in integrity, innovation, and collaboration, and we strive to foster an inclusive and diverse work environment. We believe in putting patients first and are driven by a shared mission to recover hearts and save lives.

We are an equal opportunity employer and value diversity in our workforce. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. If you require reasonable accommodation or adjustment during the application process, please let us know and we will be happy to accommodate your needs.

Join us at Johnson & Johnson and be part of a team that is making a difference in the world through our exceptional products and unwavering commitment to quality.

Required Skills:

Preferred Skills: