What’s in it for you?

The Role: The Quality Engineer is responsible for providing Quality Engineering support to ensure compliance with FDA and ISO 13485. This also includes supporting the manufacturing quality function of the company during ongoing production and shipment of Neocis products to the field.

What you’ll do:

• Perform complaint, nonconformance and CAPA reviews, investigations, containment plans and resolutions.
• Process events to determine complaint and reportability status. Complete applicable Medical Device Reports (MDR) as required per internal policy and FDA regulations
• Drive risk management activities per ISO 14971, including risk management plan, hazard analysis, FMEAs (design, software, user), risk-benefit analysis, and risk management report.
• Follow all applicable Quality and Safety procedures, including Good Documentation Practices (GDP)
• Recommend revisions of specifications, and help formulate or revise quality assurance policies and procedures to ensure alignment with regulatory requirements and best practices.
• Create monthly Quality Dashboards for leadership, highlighting trends in nonconformances or production yields.
• Design or specify inspection and testing mechanisms and equipment to monitor and assess product quality throughout the manufacturing process.
• Support Manufacturing and Quality Control departments to ensure successful manufacturing and release of products by following company standard operating procedures and process control requirements.
• Support research and development and manufacturing departments to ensure successful transition of products and processes from design to commercialization by following company standard operating procedures and design control requirements.
• Develop and Implement statistical methods to support process and product improvement activities.
• Maintain effective communications with supervisor and peers in daily activities.
• Participate in inspection support for FDA and global regulatory agencies, including research and preparation of correspondence in response to global regulatory agencies requests for additional information.

What you’ll bring:

• Bachelor’s Degree (B.S.) in Biomedical Engineering or equivalent from four-year college or university is needed.
• 1 year of experience in a Quality Assurance role in a regulated industry
• Experience with quality assurance in a small start-up environment is desired.
• Thorough understanding of Quality Management Systems (QMS), 21 CFR 820, CE Mark, ISO 13485 standards is needed.
• Ability to understand and document complex technical information.
• Team player with excellent communication skills and strong attention to detail
• Computer knowledge is required.
• Background and work experience as an engineer in developing a medical device is an advantage.
• Project/team lead experience is a plus.
• Ability to read, analyze, and interpret common scientific and technical journals and standards
• Ability to effectively present information to various internal and external customers

What else?

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Reasonable accommodation may be made to enable candidates with disabilities to perform this role.

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