The Design Quality Engineer will develop and implement compliance strategies to support new product introductions & development within the areas of design, design transfer, manufacturing, and service. The Design Quality Engineer will ensure adherence to Quality Management Systems and regulatory requirements, use critical thinking and influencing skills to work cross-functionally to ensure robust quality decisions, and create a Quality culture by driving compliance activities.
ESSENTIAL FUNCTIONS:
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Work with high-performing cross-functional teams to sustain the quality of medical device products
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Responsible for Quality functions that impact patient care by ensuring the safety, quality, audit readiness, post-market performance, and compliance of products
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Interface with cross-functional teams to complete sustaining projects, design control deliverables, and activities to ensure that medical device products continue to meet state-of-the-art regulatory standards and user needs
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Effectively work with and influence cross-functional teams during the Design Change process to ensure proposed changes to products are systemically and thoroughly analyzed, assessed, controlled, and implemented appropriately (i.e., EN 13485 / CFR820)
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Support Risk Management planning, updating, and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with company and various industry standards
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Support Usability Engineering and planning documentation
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Support the sustaining effort for both product and packaging designs
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Support manufacturing operation efforts and changes to ensure they meet or exceed internal and external requirements
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Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem-solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues
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Support post-market activities ensuring products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals
Computer Skills:
Advanced computer skills are required, including MS Office applications (Word / Excel/ Visio / PowerPoint / Project) and Minitab statistical analysis software.
Knowledge of statistical techniques and sampling for process validation and process monitoring is required.
Experience with Agile PLM or other documentation management systems desired.
Education: Bachelor’s Degree in Engineering or equivalent work experience.
Experience:
- +7 years of direct Quality/Design Quality engineering experience in the medical device industry required.
- Demonstrate the use of quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, and process validation (IQ, OQ/PQ).
- Must have a good understanding of FDA 21CFR820, ISO 13485,14971, and 11607 standards. Demonstrate interpersonal skills with the ability to work within a team environment.
- Excellent written and verbal communication skills with good presentation and technical writing skills. Proficiency in all Microsoft Office programs. Good analytical and problem-solving skills.
- Strong engineering, design, and analysis skills.
- Knowledge of tooling and manufacturing processes.
- Experience with medical devices from concept to commercialization.
- Understanding of FDA Quality Systems Regulations.
- CQE certification is desired.
- Six Sigma black belt is a plus.
Enhanced Compliance, Inc. (ECI) is a trusted consulting firm distinguished by our specialized expertise and comprehensive range of services tailored to the life sciences industry. Our team boasts profound expertise and hands-on experience across all functional aspects throughout the full product lifecycle, allowing us to provide targeted solutions that solve the unique challenges faced by our clients. Our consulting team comprises exceptional talent with diverse backgrounds, skills, and experiences. We take pride in their expertise and caliber, which are key differentiators for our firm. Our consultants bring a wealth of knowledge and a collaborative mindset to every engagement, ensuring that our clients benefit from the collective wisdom and experience of our team.