Senior Design Quality Engineer
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תקציר
As Senior Design Quality Engineer, you will lead and support Quality activities for R&D, including medical device software development, in accordance with current standards, regulatory requirements and company procedures.
דרישות
- Bachelor’s degree in engineering, science or technical field or equivalent, Master's degree preferred.
- Minimum 7 years of experience in the highly regulated multidisciplinary medical device industry in Quality, R&D or Regulatory roles with direct responsibility for Design Controls.
- Proven hands-on experience in medical device R&D environments, working closely with multidisciplinary development teams (software, hardware, systems and clinical) throughout the product development lifecycle.
- Experience in medical device software quality, including Software as a Medical Device (SaMD), covering the software development lifecycle, software verification and validation.
- Experience supporting software tools validation in a regulated environment (e.g. risk-based computer software assurance (CSA) and 21 CFR Part 11 / electronic records and signatures).
- Strong knowledge of Quality Management Systems, Design Controls, GMP, Risk Management, Internal Audits, CAPA, Change Control and Documentation Controls.
- Working experience with applicable regulations and standards (including, but not limited to): ISO13485:2016, FDA 21 CFR 820 (QMSR), EU MDR, MDSAP, ISO 14971, IEC 62304 and IEC 62366-1.
- Ability to transfer technical expertise by teaching, developing and mentoring employees.
- Process detailed & results oriented.
- Ability to work in a fast-paced environment team and in line with the company’s values.
- Well organized, with the ability to deliver results on several projects simultaneously.
- Strong oral and written communication skills.