Senior Design Quality Engineer

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Written by AI from the job title and company, not by CooperSurgical, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Senior Design Quality Engineer at CooperSurgical plays a pivotal role in ensuring that our medical devices meet the highest quality standards throughout the design and development process. This position involves collaborating with cross-functional teams to oversee quality aspects from concept through commercialization, all while advocating for product performance and regulatory compliance. The Engineer will be responsible for identifying potential risks, facilitating design verification and validation activities, and driving continuous improvement initiatives to enhance product quality and reliability.

Job Responsibilities

• Collaborate with design teams to establish and implement quality assurance processes in line with regulatory requirements.
• Conduct risk assessments and analyze data to identify areas for improvement in product designs.
• Lead design verification and validation activities to ensure compliance with FDA, ISO, and other relevant standards.
• Document and maintain quality management system procedures and protocols related to product design and development.
• Facilitate quality training sessions for team members to ensure understanding and adherence to quality standards.
• Participate in cross-functional project meetings to advocate for quality throughout the product development lifecycle.
• Support internal and external audits, providing necessary documentation and guidance.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or a related field; a Master’s degree is preferred.
• Minimum of 5 years of experience in quality engineering within the medical device industry.
• Strong knowledge of design control, risk management, and validation methodologies.
• Familiarity with FDA regulations, ISO 13485, and other applicable industry standards.
• Excellent analytical and problem-solving skills, with a keen attention to detail.
• Proficient in quality tools such as FMEA, Root Cause Analysis, and Statistical Process Control.
• Effective communication skills, both written and verbal, with the ability to work collaboratively in a team environment.

Technologies & Tools

The Senior Design Quality Engineer will utilize a variety of technologies and tools including, but not limited to, quality management software, statistical analysis tools, and design simulation software. Familiarity with electronic document management systems (EDMS) and enterprise resource planning (ERP) systems is essential for maintaining compliance and compaction of documentation.

Ideal Candidates

Ideal candidates for the Senior Design Quality Engineer position will exhibit a proactive approach to quality assurance and a commitment to continuous improvement. They are meticulous, detail-oriented professionals who thrive in collaborative environments and possess robust leadership capabilities. Strong decision-making skills and the ability to effectively manage multiple projects are essential, as is a genuine passion for enhancing patient safety and product effectiveness.