Quality Management Engineer - Design Controls - National Remote

Lensa; Minnetonka (MN); Remote; USD 89,000 - 177,000; Full time

Job summary

An established industry player is seeking a Quality Management Engineer to enhance their Quality Management System. This role involves collaborating with cross-functional teams to ensure product quality throughout the software lifecycle. You will implement design controls, monitor product quality metrics, and promote a culture of quality and safety. With a performance-driven environment and opportunities for growth, this position allows for remote work flexibility across the U.S. If you have a knack for problem-solving and a passion for quality, this could be the perfect opportunity for you.

Qualifications

• Experience in Quality Management Systems and design controls.
• Ability to analyze product quality metrics and support risk analysis.

Responsibilities

• Ensure adherence to quality standards and regulations.
• Develop quality plans and oversee product quality metrics.
• Conduct training on quality topics and support audits.

Skills

Software as Medical Device

Problem-solving skills

Business-oriented mindset

Job description

Quality Management Engineer - Design Controls - National Remote

The Quality Management Engineer – Design Controls will play a crucial role in ensuring the implementation of the ‘fit for purpose’ Quality Management System within the OI CDS team. You will collaborate with cross-functional teams to ensure timely completion of activities throughout the software product lifecycle. Responsibilities include implementing design controls, analyzing product quality metrics, supporting product risk analysis, monitoring complaints, and conducting training sessions.

We seek candidates experienced with Software as Medical Device, possessing a business-oriented mindset and pragmatic problem-solving skills.

This position offers the flexibility to telecommute from anywhere within the U.S.

Primary Responsibilities

• Ensure adherence to relevant Regulations, Standards, and Quality Management System processes
• Guide product team members in establishing and maintaining the Design History File (Engineering File)
• Develop and oversee quality plans for products
• Review engineering deliverables and provide constructive feedback
• Conduct milestone reviews for products
• Support product risk analysis, evaluation, control, residual risk assessment, and post-market monitoring
• Assist in complaint monitoring and tracking
• Develop and deliver training on relevant quality topics
• Participate in corrective and preventive actions and quality audits
• Drive process improvements collaboratively with cross-functional teams
• Promote a culture of quality and safety within the product line
• Analyze product quality metrics, report deviations, and escalate issues for timely intervention

We offer a performance-driven environment with clear success metrics, development opportunities, and a comprehensive benefits package. The salary range is $89,800 to $176,700 annually, based on experience, education, certifications, and location. All applicants will be considered in accordance with applicable laws and policies.