Principal Design Quality Engineer - Digital (Remote)

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

Job Overview

The Principal Design Quality Engineer - Digital at Stryker is responsible for ensuring that the quality standards of digital products are met and maintained throughout the product lifecycle. This role involves collaborating closely with cross-functional teams to innovate, develop, and validate digital solutions that meet regulatory requirements and exceed customer expectations. The individual will lead quality initiatives, enforce compliance, and mentor junior team members, playing a vital role in advancing Stryker's commitment to high-quality healthcare solutions.

Job Responsibilities

• Lead and manage digital product quality assurance activities, ensuring compliance with FDA, ISO, and other regulatory standards.
• Develop and implement quality plans, procedures, and practices for digital products.
• Conduct risk assessments and facilitate design reviews across product development stages.
• Collaborate with product teams to review specifications and ensure quality requirements are integrated into product designs.
• Identify, analyze, and resolve quality issues, implementing corrective actions and preventative measures.
• Mentor and guide junior quality engineers in best practices and methodologies.
• Facilitate root cause analysis and lead investigations into non-conformance events.
• Participate in audits and inspections, ensuring readiness and compliance.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related field; Master’s degree preferred.
• Minimum of 7 years of experience in quality engineering or related roles, with at least 3 years in a regulatory environment.
• In-depth knowledge of design control, risk management, and validation processes.
• Familiarity with digital healthcare products and software development life cycle (SDLC).
• Strong analytical skills with a detail-oriented mindset.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a cross-functional team environment.
• Proficiency in quality management systems and tools.

Technologies & Tools

The Principal Design Quality Engineer - Digital will utilize various technologies and tools, including but not limited to electronic quality management systems (eQMS), risk management software, design control applications, and statistical analysis tools. Familiarity with agile methodologies and DevOps practices for software development will also be essential.

Ideal Candidates

The ideal candidate for this position will be one who possesses a proactive attitude aimed at driving quality improvements while demonstrating exceptional problem-solving capabilities. Strong leadership traits and a passion for mentoring others, combined with excellent organizational skills and a commitment to continuous improvement, will mark the ideal individual for this role. A penchant for collaborating in a fast-paced, dynamic environment is critical, as well as a focus on delivering results that align with Stryker's mission of providing exceptional healthcare solutions.