What are the responsibilities and job description for the Senior Quality Engineer position at Neocis, Inc.?
About us
Neocis is an established start-up revolutionizing dentistry with Yomi, the first, and only FDA cleared robot for assisted dental surgery. The company collaborates closely with leading clinicians to develop innovative technologies that help advance patient care and improve quality of life. Based in Miami, Florida. Neocis is venture-backed with funding from several prominent investors.
What’s in it for you?
- You’ll thrive in our innovative and collaborative environment
- Make an immediate impact on life-changing technology
- Avoid silos and “not my job” mentality in our smaller, fast paced, startup environment
- We offer sabbatical, parental leave and unlimited PTO policies
- Generous 401K plan with 4% company match
- Comprehensive benefits package that includes medical, dental and vision.
The Role:
The Senior Quality Engineer is responsible for supporting Design Quality Engineering and Quality Management Systems functions. Responsibilities include supporting the creation and ownership of the procedures and records required for the development, verification, validation, and design transfer of Neocis products to assure the ongoing quality of products and maintain compliance with ISO 13485, ISO14971, FDA QSRs, MDSAP, and EU Medical Device Regulations.
What you’ll do:
- Supports research and development to ensure the successful transition of products and processes from design to production by following company standard operating procedures and design control requirements.
- Collaborates with engineering and manufacturing functions to ensure quality standards related to design control are in place.
- Supports the Manufacturing Quality team by devising and implementing methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment as part of design transfer.
- Supports the design and specification of inspection and testing mechanisms and equipment, conducts quality assurance tests, performs statistical analysis, and determines root cause of products or materials that do not meet required standards and specifications.
- Supports Material Review Board with the disposition and correction process.
- Provides guidance and training to basic design control processes to Engineering, Quality, and Operations team members.
- Ensures that corrective measures for design control related matters meet acceptable standards with appropriate statistical methodologies, and that documentation is compliant with internal and external requirements and regulations.
- Leads strategic design control related Quality initiatives and supports Quality Management and Leadership Team to plan, source, and implement company-wide and Quality system improvements.
- Reviews new/changed equipment, process validations, design changes, nonconformances, etc., to ensure compliance and assess the impact on product reliability, process capability, and compliance status.
- Reviews and approves test method validation and Gage RnR protocols and reports.
- Supports and participates in planned and unplanned internal and external audits.
- Execute Internal and/or Supplier Audits
- Identify, analyze, and manage risk through product life cycle with use of ISO14971.
- May perform regulatory support as required.
- Supports the management of the company’s QMS including the company’s eQMS platform application (Arena)
What you’ll bring:
- Bachelor’s Degree (B.S.) in Biomedical Engineering or equivalent from four-year college or university is needed.
- 3-5 years of experience in a Quality Assurance role in a regulated industry
- Experience with FDA medical device regulations including 510(k) submissions.
- Competent in Quality Management Systems (QMS) and 21 CFR 820, MDSAP, ISO13485, and EU MDR
- Competent in understanding and documenting complex technical information.
- Team player with proficient communication skills and strong attention to detail
- First-hand experience with medical device software, electronics, and manufacturing
- Competent with US and international standards like CE mark and FDA QSR's
- Competent in reading, analyzing, and interpreting common scientific and technical blueprints, journals, and standards
- Competent in effectively presenting information to various internal and external customers
- Experience with quality assurance in a small start-up environment preferred
- Background and work experience as an engineer developing medical devices.
- American Society for Quality (ASQ) or equivalent Quality Engineer certification preferred
- American Society for Quality (ASQ) or equivalent Lead/Internal Auditor certification preferred
- Competent with Root Cause Analysis
- Proficient with Risk Management ISO14971
- Lean Six Sigma tools knowledge is a plus
What else?
- This is not a supervisory role
- This is a full-time position. This position occasionally requires long hours and weekend work.
- The position will require up to 5% travel in and out of state
- The main location of this role is in a medical devices manufacturing facility and requires:
- This position requires the regular use of office and role specific equipment
- Prolonged periods working on a computer
- Ability to lift/push/carry items up to 30 pounds
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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