Sr Manufacturing Quality Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function :

Supply Chain Engineering

Job Sub Function : Quality Engineering

Job Category :

Scientific / Technology

All Job Posting Locations :

Aachen North Rhine-Westphalia Germany

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 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 75000 - 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 Bachelors 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 :

Coaching Consistency Controls Compliance Critical Thinking Data Savvy Engineering Financial Competence Good Automated Manufacturing Practice (GAMP) ISO 9001 Lean Supply Chain Management Leverages Information Process Improvements Quality Control (QC) Quality Standards Quality Systems Documentation Quality Validation Science Technology Engineering and Math (STEM) Application Technologically Savvy

Required Experience :

Senior IC

Key Skills

Lean Manufacturing,Six Sigma,CNC Programming,Lean,Machining,Tooling,CAD,CNC,Assembly Experience,SolidWorks,Kaizen,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1