Quality Engineer, Production

AMT Medical, a pioneering Medical Device company developing a heart bypass procedure. AMT aims to transform Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. This innovative, minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without using a heart-lung machine, thereby reducing patient impact and speeding up recovery.

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The Quality Engineer, Production will be responsible for ensuring that all manufacturing activities for our Class III cardiovascular devices are conducted in a compliant and efficient manner. This senior role will not only manage critical quality functions but will also mentor and guide a team the production staff, ensuring a culture of quality compliance. The ideal candidate will have extensive experience in medical device manufacturing, with a strong focus on process validation, supplier quality management, and quality control.

Key Responsibilities:

·      Manufacturing Process Validation: Support all process validation activities froma quality perspective (Installation Qualification, Operational Qualification, Performance Qualification) for new and existing manufacturing processes. Ensure all validation activities comply with FDA and ISO requirements. Provide technical leadership to production and engineering teams to resolve complex process issues and drive continuous improvement.

·      Supplier Control: Manage the company's supplier quality program. This includes performing supplier audits, managing supplier corrective actions (SCARs), and ensuring all incoming materials meet quality specifications. Work closely with procurement and Design and Development to vet and qualify new suppliers and maintain a robust approved supplier list.

·      Quality Control (QC) & Inspection: Oversee the Quality Control function, ensuring that all finished products meet stringent quality standards before release. Develop and implement statistically sound sampling plans, inspection procedures, and acceptance criteria. Provide hands-on support and technical expertise to resolve complex inspection issues.

·      Team Leadership & Mentorship: Provide training and guidance on quality principles, regulatory requirements, and best practices in medical device manufacturing. Establish a collaborative environment and empower the team tosolve problems proactively.

·      Regulatory Compliance: Ensure all manufacturing and quality control processes adhere to global medical device regulations and quality system standards, including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and EU Medical Device Regulation (MDR).

·      CAPA & Non conformance: Lead investigations for manufacturing nonconformances and customer complaints, driving root cause analysis and implementing effective corrective and preventive actions (CAPA) and ongoing process improvements.

Required Qualifications:

·      Bachelor's degree in engineering or a related scientific or technical field.

·      Minimumof 5 years of experience in a Quality Engineering role within the medical device industry.

·      Proven experience working with Class III medical devices, preferably in the cardiovascular or a related high-risk therapeutic area.

·      Extensive experience with manufacturing process validation (IQ/OQ/PQ) and developing test methods in a cleanroom setting.

·      In-depth knowledge and practical experience with supplier quality management.

·      Demonstrated expertise in Quality Control (QC), inspection methods, and statistical analysis.

·      Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485 and EU Medical Device Regulation (MDR).

·      Experience in Risk Management ISO14971 and its application in a medical manufacturing environment.

·      Perform Root-cause analysis following Lean Six-Sigma principles,

Preferred Qualifications:

·      Master'sdegree in a relevant field.

·      Previous experience in a senior or lead role with direct reports or mentorship responsibilities.

Skills and Attributes:

·      Excellent leadership and communication skills, with a talent for teaching complex concepts.

·      Problem solver with a passion for quality and results

·      Strong analytical and problem-solving abilities, with a methodical approach to root cause analysis.

·      Exceptional attention to detail and a commitment to producing high-quality work.

·      Ability to work effectively in a dynamic, fast-paced manufacturing environment.

Organization & Offer:

Join AMT Medical, a dynamic scale-up poised to redefine cardiac care. Positioned at theforefront of innovation, AMT Medical offers a collaborative and flexible work environment where your contributions significantly impact patient outcomes. With a large-scale clinical trial running since 2024, now is an exciting time to come aboard. Based in Utrecht and Ede, AMT Medical offers a competitive salary and benefits package, along with substantial opportunities for professional growth and leadership development.

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