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.

Overview

The Principal Design Quality Engineer - Digital at Stryker plays a pivotal role in ensuring that digital products meet stringent quality and regulatory standards throughout the product lifecycle. This position involves a combination of strategic oversight, collaboration with cross-functional teams, and direct involvement in quality assurance processes. The successful candidate will leverage their engineering expertise to provide guidance and support in the development and verification of high-quality digital solutions while ensuring compliance with applicable regulations and internal policies.

Job Responsibilities

• Develop and implement quality assurance strategies for digital products to ensure compliance with regulatory requirements.
• Lead cross-functional teams in the evaluation of design and development processes to identify quality risks and implement corrective actions.
• Conduct risk assessments and influence product development teams in applying best practices for design controls.
• Review and approve documentation related to design quality, including plans, specifications, and reports.
• Provide expert consultation on quality issues during product development, clinical trials, and post-market surveillance.
• Perform root cause analysis and develop strategies for continuous improvement in design quality processes.
• Train and mentor team members on quality assurance processes and regulatory requirements.

Qualifications

• Master's degree in Engineering, Quality Assurance, or a related field; equivalent experience considered.
• A minimum of 7 years of experience in quality engineering or related roles, preferably within the medical device or aerospace industries.
• In-depth knowledge of ISO 13485, FDA QSR, and other relevant standards and regulations.
• Strong analytical skills and experience with statistical analysis methodologies.
• Proven ability to lead projects and cross-functional teams effectively.
• Excellent communication skills, both written and verbal, with the ability to convey complex information clearly.
• Certifications in quality engineering (e.g., CQE, CQA) are highly desirable.

Technologies & Tools

This position utilizes a variety of technologies and tools essential for quality engineering in the digital landscape. These include software applications for project management and documentation such as JIRA, Confluence, and quality management systems (QMS). Additionally, candidates should be familiar with data analysis and visualization tools such as Minitab or Tableau, as well as simulation software relevant to product design and testing.

Ideal Candidates

The ideal candidate for the Principal Design Quality Engineer - Digital role is a proactive and detail-oriented professional with a strong passion for quality and innovation. They possess a robust technical background and exhibit exceptional problem-solving skills, allowing them to navigate complex challenges effectively. A collaborative mindset, along with excellent interpersonal skills, is essential for fostering strong relationships across various teams. The ability to remain resilient in a fast-paced environment, coupled with a commitment to continuous learning and improvement, distinguishes an exceptional candidate in this role.