What are the responsibilities and job description for the Quality Manager 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 Quality Manager is responsible for managing the Design Quality Engineering and Quality Management Systems functions. Responsibilities include supporting the creation of (and times when needed 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 applicable design control requirements/ regulations.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Facilitates the design transfer process by ensuring that manufacturing, engineering, and quality teams fully understand the design outputs and associated risks.
- Assists in the design and specification of inspection and testing systems and equipment;
- Performs necessary quality assurance tests, conducts statistical analysis, and identifies the root cause of products or materials that fail to meet required standards and specifications.
- Supports non-conforming product disposition and corrections for design related issues.
- Provides guidance and training to basic design control processes to Engineering, Quality, and Operations team members.
- Ensures that corrective measures for design control meet acceptable standards with appropriate statistical methodologies, and that documentation is compliant with requirements.
- Ensures, guides, and leads the execution of FDA, EU MDR, and ISO 13485 design control methods, regulations, and requirements.
- Leads strategic design control Quality initiatives and supports Quality Management and Leadership Team to plan, source, and implement company-wide and Quality system improvements.
- Reviews and approves test method validation and Gage R&R protocols and reports related to design control.
- Reviews and approves software verifications and validations
- Reviews and approves Human Factors validations
- Leads planned and unplanned internal and/or external audits.
- Conducts Internal and/or Supplier Audits
- Identify, analyze, and manage risk through the product life cycle in compliance with ISO14971.
- May perform regulatory support as required.
- Manages the company’s QMS including the company’s eQMS platform application (Arena)
- Responsible for managing any resources related to Design Quality and the QMS
- Serves as the company’s Management Representative and conducts Management Review meetings with Management with Executive Responsibility to report on the ongoing suitability of the company’s QMS.
- Reports on the status of the QMS per internal quality requirements
What you’ll bring:
- Bachelor’s degree in engineering, Science, or technical field with 7 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science, or technical field in a regulated industry (medical devices preferred)
- 7 years of experience in a Quality role
- Proficient with FDA medical device regulations including 510(k) submissions.
- Expert in Quality Management Systems (QMS) and 21 CFR 820, 21 CFR 807, EU MDR, MDSAP, and ISO13485.
- Expert in understanding and documenting complex technical information.
- Team player with excellent communication skills and strong attention to detail
- First-hand experience with medical device software, electronics, and manufacturing
- Proficient
- Proficient in reading, analyzing, and interpreting common scientific and technical journals and standards
- Expert in effectively presenting information to various internal and external customers
- Proficient in managing a team
- Proficient with quality assurance in a small start-up environment preferred
- American Society for Quality (ASQ) or equivalent Quality Engineer certification preferred
- American Society for Quality (ASQ) or equivalent Lead/Internal Auditor certification preferred
- Proficient in risk management regulations and requirements ISO14971.
- Lean Six Sigma tools knowledge is a plus
What else?
- This is a supervisory role, managing the R&D Quality Engineering and QMS functions for the company.
- 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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