Senior Quality Engineer (m/w/d)

Bruker Corporation; Bremen, Bochum; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Quality Engineer to enhance quality management processes in the medical device sector. This pivotal role involves providing engineering support throughout the product lifecycle, from design to implementation, ensuring compliance with regulatory standards. The ideal candidate will possess extensive experience in quality engineering, particularly within a regulated environment, and will be adept at mentoring junior engineers. Join a dynamic team dedicated to making a positive impact on human health through innovative solutions and quality assurance practices. This is a fantastic opportunity to contribute to groundbreaking projects that improve lives.

Qualifikationen

• 5+ years of experience in Quality Engineering, especially in medical devices.
• Strong understanding of FDA QSR, ISO 13485, and risk management standards.

Aufgaben

• Provide quality engineering support for medical device design and development.
• Mentor junior quality engineers and assist in quality policy development.

Kenntnisse

Quality Engineering

Risk Management

Process Validation

Statistical Process Control

Communication Skills

Ausbildung

Bachelor's in Engineering

Degree in STEM field

Tools

MasterControl

Minitab

Jobbeschreibung

Overview

Bruker is one of the world’s leading analytical instrumentation companies enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Our high-performance products and high-value life science and diagnostics solutions are trusted by leading businesses, institutes, and scientists worldwide. Today, more than 9,700 employees at over 100 locations are working on this permanent challenge to make the world a better place.

For our quality management team in Bremen, we are looking for a Senior Quality Engineer.

Responsibilities

1. Provide quality engineering support in design, development, and sustaining activities for low, moderate, and complex medical device (IVD) and other (RUO) products.
2. Focus on quality engineering of design inputs and design outputs like risk management files, and work closely with the production quality engineers for design transfer and sustaining engineering activities.
3. Ability to digitize processes in standard tools (e.g., MasterControl), also across several sites, and participate in the development of the company's IT strategy (CRM, ERP, quality management tools like MasterControl, and document and record repository strategy).
4. Capable of mentoring junior-level quality engineers in providing quality engineering support for their product lines and teams.
5. This position may be called upon to provide support for operations and quality systems by assisting in the development and implementation of quality policies and procedures.

Qualifications

1. Sc. / B.A. in Engineering or a specific scientific field.
2. Minimum 5 years of experience in Quality Engineering.
3. Working knowledge of the requirements of FDA QSR, ISO 13485, and ISO 9001, IVDR, risk management (ISO 14971, D-FMEA, P-FMEA, RBA).
4. Degree in engineering or related STEM field.
5. Strong design control understanding from concept to launch (e.g., product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied during the product development process).
6. Competency in Process Validation (IQ, OQ, PQ), Control Plans, DOE, Statistical Process Control, and Capability Analysis helpful.
7. Excellent verbal and written communication skills, in German and English.
8. Multi-year (5y+) previous experience working in a regulated or medical device development environment as well as in a cross-functional team environment.
9. Experience with electronic quality management systems (like MasterControl) and statistical tools (e.g., Minitab) are helpful.