About Zenflow
Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring® technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is an investigational device and is not approved for commercial sale.
POSITION OVERVIEW:
We are a dynamic medical device start-up seeking a highly skilled and motivated Senior Quality Engineer to join our team. The ideal candidate will play a crucial role in ensuring our products meet the highest standards of quality and regulatory compliance. This position involves working closely with cross-functional teams to support product development, manufacturing, post-market, and overall quality system activities.
MAJOR DUTIES AND RESPONSIBILITIES:
Product Development Support:
- Participate in new and modified product development projects.
- Establish product specifications and support manufacturing process validation.
- Develop and review new and revised test methods, validation protocols, and reports (IQ, OQ, PQ).
- Conduct risk management activities, including Hazard Analysis, dFMEA, uFMEA, and pFMEA.
Quality Management System (QMS):
- Maintain and improve the QMS in compliance with FDA, ISO 13485, and other applicable regulatory requirements.
- Conduct internal and supplier audits to ensure compliance with quality standards.
- Support external regulatory body audits and inspections.
Non-Conformance and CAPA:
- Investigate and resolve non-conformances and product complaints.
- Lead root cause analysis and implement corrective and preventive actions (CAPA) as appropriate.
- Track and analyze quality metrics to monitor processes and identify trends and areas for improvement.
Supplier Quality Management:
- Qualify new suppliers and manage supplier performance.
- Conduct supplier audits and supplier re-qualifications to ensure supplier compliance with quality requirements and implementation of corrective actions.
Post-Market Surveillance:
- Review and maintain post-market surveillance data and files.
- Track and report on product-related non-conformances and complaint status.
Continuous Improvement:
- Lead and champion continuous improvement.
- Analyze key performance indicators and drive quality improvements.
EDUCATION/EXPERIENCE REQUIREMENTS:
- Bachelor’s or Master’s degree in Engineering, Science, or a related field (e.g., Mechanical, Biomedical, Quality Engineering), or equivalent experience.
- Minimum of 5 years of experience in quality engineering, R&D, or manufacturing within the medical device or MedTech industries, or other appropriate technical experience.
- Certified Quality Engineer (CQE) certification from the American Society for Quality (ASQ) is preferred.
- In-depth knowledge of FDA QSR Part 820, ISO 13485, and EU Medical Device Regulations.
- Hands-on experience with Design Verification and Validation (V&V) test plan development, test method validation, execution, and report review.
- Proficiency in risk management tools such as FMEA and root cause analysis.
- Strong analytical skills and experience with statistical process control and design of experiments, and overall valid statistical analysis.
- Excellent communication and teamwork skills, with the ability to work effectively in a fast-paced start-up environment.
- Experience with Lean Manufacturing tools and techniques is an advantage.
- Experience with collecting, analyzing, and presenting quality system performance data for Management Reviews a plus.
- Familiarity with international regulatory requirements (e.g., MDR, TGA, PMDA) a plus.
- Experience with electronic Quality Management Systems (eQMS) preferred.
- Proven track record of successful project management and leadership in a quality engineering role.
- Ability to work independently and balance multiple priorities in a fast-paced, FDA regulated environment.
- Strong verbal and written communication skills.
- Strong organizational and planning skills, with an attention to detail.The expected salary range for this position is $105,000 - $125,000 plus equity and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.
