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. 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.

This position can be either a specialist or senior specialist level, based on level of experience and qualifications.

Responsibilities and Duties:

• Provide quality engineering support in the development and manufacturing of new and existing medical devices.

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

• Lead Quality reporting such as, key performance metrics, goals, and objectives.

• Lead and support activities related to the Material Review Board.

• 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.

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

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

• 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.

Qualifications:

• A Bachelor's degree in a relevant Engineering /Applied Science/ or equivalent field is necessary.

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

• Experience with manufacturing of complex products in environmentally controlled area, catheter-based or cardiac assist devices preferred. Equivalent experience in the manufacturing of highly regulated products will also be considered.

• Experience with formal problem-solving methodologies, risk management (e.g.: FMEAs) 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.

• Drives accountability for quality compliance and champion a proactive quality, compliance and risk based driven culture

• Provides leadership to assure day-to-day decisions are well supported and documented

• Leads site/global projects striving to simplify / streamline processes across the organization, eliminate redundancies and further improve compliance in a changing healthcare environment.

• Comfortable in collaborating in cross-functional and multi-cultural teams

• Advanced in German and English is required

The anticipated base pay range for a senior specialist position is 75,000 to 118,450 Euro.

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: