R&D Quality Engineering Manager/Director
3.
0 Quick Apply 3 hours ago Full Job Description 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:
R&D Quality Engineering Manager The R&D Quality Engineering Manager is responsible for managing the R&D Quality Engineering team which provides support, guidance and leadership to site R&D, manufacturing, quality control and other company departments.
Responsibilities include the procedures and records required for the development, validation and production of Neocis products and processes in order to assure the ongoing quality of products and maintain compliance with ISO 13485, FDA QSRs, and EU Medical Device Regulations.
What you'll do 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, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product Collaborate with engineering and manufacturing functions to ensure quality standards are in place Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment as part of design transfer Design or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests, as required; and performs statistical analysis and determines the responsibility for products or materials that do not meet required standards and specifications Handle potential non-conforming processing, shipments and manufacturing and escalate to Quality Management and/or Executive Management Review and approve various Quality System documentation and reports with focus on R&D that may include but not limited to Change Management, New product development, product and process validations, and quality procedures Provides guidance and training to Engineering, Quality team members and Operations Ensures that corrective measures meet acceptable standards and that documentation is compliant with requirements Specializes in the areas of design control with experience in design transfer i.
e.
, production and process controls, supplier controls, Quality Management Systems, as they apply to product or process quality As part of design control, applies and understands statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement Leads strategic Quality initiatives and supports Quality Management and Leadership Team to plan, source and implement company-wide and Quality system improvements Reviews equipment and process validations, changes, nonconformances, etc.
, in order to ensure compliance and assess the impact on product reliability, process capability and compliance status Reviews and approves test method validation and stability plans and reports Leads and/or participate in corrective/preventive action teams in resolving production, customer and supplier issues (e.
g.
, nonconformances, CAPA or CAPA activities, audit findings, complaint investigations, etc.
) Supports and participates in planned and unplanned internal, regulatory and/or notified body audits.
Provides information that is timely, accurate and substantiated by objective evidence Conducts R&D, manufacturing, quality control tasks per approved operational procedures or as defined by the requestor of the tasks Assures that all measuring instruments that are used are within calibration limits.
Ensures that all activities are carried out within regulations and laws governing business and quality operations Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance May be trained as Internal and/or Supplier Auditor Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk management tools May perform regulatory support as required What you'll bring Bachelor's Degree in Engineering, Science, or technical field with 10
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 QA / RA role Experience with FDA medical device regulations including 510(k) submissions Thorough understanding of Quality Management Systems (QMS) and 21 CFR 820 with particular focus on design controls Ability to understand and document complex technical information Team player with excellent communication skills and strong attention to detail First-hand experience with medical device software, electronics and manufacturing Experience with international standards like CE marks, ISO 13485, EU MDR Ability to read, analyze and interpret common scientific and technical journals and legal documents.
Ability to effectively present information to various internal and external customers Ability to comprehend and apply principles of advanced calculus, modern algebra and advanced statistical theory.
Ability to work with concepts such as limits, rings, quadratic and differential equations.
Experience managing a team Experience with quality assurance in a small start-up environment Background and work experience as an engineer in developing a medical device American Society for Quality (ASQ) or equivalent Quality Engineer certification American Society for Quality (ASQ) or equivalent Lead/Internal Auditor certification Root Cause Analysis Training and experience is a plus Lean Six Sigma tools knowledge is a plus What else? This is a supervisory role.
This position manages R&D Quality Engineering team.
This position's responsibilities include:
interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; developing and promoting employees; addressing complaints and resolving problems The position will require up to 5% travel in and out of state Reasonable accommodation may be made to enable candidates with disabilities to perform this role 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 Other Duties 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.
Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
0 Quick Apply 3 hours ago Full Job Description 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:
R&D Quality Engineering Manager The R&D Quality Engineering Manager is responsible for managing the R&D Quality Engineering team which provides support, guidance and leadership to site R&D, manufacturing, quality control and other company departments.
Responsibilities include the procedures and records required for the development, validation and production of Neocis products and processes in order to assure the ongoing quality of products and maintain compliance with ISO 13485, FDA QSRs, and EU Medical Device Regulations.
What you'll do 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, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product Collaborate with engineering and manufacturing functions to ensure quality standards are in place Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment as part of design transfer Design or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests, as required; and performs statistical analysis and determines the responsibility for products or materials that do not meet required standards and specifications Handle potential non-conforming processing, shipments and manufacturing and escalate to Quality Management and/or Executive Management Review and approve various Quality System documentation and reports with focus on R&D that may include but not limited to Change Management, New product development, product and process validations, and quality procedures Provides guidance and training to Engineering, Quality team members and Operations Ensures that corrective measures meet acceptable standards and that documentation is compliant with requirements Specializes in the areas of design control with experience in design transfer i.
e.
, production and process controls, supplier controls, Quality Management Systems, as they apply to product or process quality As part of design control, applies and understands statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement Leads strategic Quality initiatives and supports Quality Management and Leadership Team to plan, source and implement company-wide and Quality system improvements Reviews equipment and process validations, changes, nonconformances, etc.
, in order to ensure compliance and assess the impact on product reliability, process capability and compliance status Reviews and approves test method validation and stability plans and reports Leads and/or participate in corrective/preventive action teams in resolving production, customer and supplier issues (e.
g.
, nonconformances, CAPA or CAPA activities, audit findings, complaint investigations, etc.
) Supports and participates in planned and unplanned internal, regulatory and/or notified body audits.
Provides information that is timely, accurate and substantiated by objective evidence Conducts R&D, manufacturing, quality control tasks per approved operational procedures or as defined by the requestor of the tasks Assures that all measuring instruments that are used are within calibration limits.
Ensures that all activities are carried out within regulations and laws governing business and quality operations Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance May be trained as Internal and/or Supplier Auditor Identify, analyze, and manage risk through product life cycle with use of FMEA and other risk management tools May perform regulatory support as required What you'll bring Bachelor's Degree in Engineering, Science, or technical field with 10
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 QA / RA role Experience with FDA medical device regulations including 510(k) submissions Thorough understanding of Quality Management Systems (QMS) and 21 CFR 820 with particular focus on design controls Ability to understand and document complex technical information Team player with excellent communication skills and strong attention to detail First-hand experience with medical device software, electronics and manufacturing Experience with international standards like CE marks, ISO 13485, EU MDR Ability to read, analyze and interpret common scientific and technical journals and legal documents.
Ability to effectively present information to various internal and external customers Ability to comprehend and apply principles of advanced calculus, modern algebra and advanced statistical theory.
Ability to work with concepts such as limits, rings, quadratic and differential equations.
Experience managing a team Experience with quality assurance in a small start-up environment Background and work experience as an engineer in developing a medical device American Society for Quality (ASQ) or equivalent Quality Engineer certification American Society for Quality (ASQ) or equivalent Lead/Internal Auditor certification Root Cause Analysis Training and experience is a plus Lean Six Sigma tools knowledge is a plus What else? This is a supervisory role.
This position manages R&D Quality Engineering team.
This position's responsibilities include:
interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; developing and promoting employees; addressing complaints and resolving problems The position will require up to 5% travel in and out of state Reasonable accommodation may be made to enable candidates with disabilities to perform this role 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 Other Duties 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.
Quick Apply.
Estimated Salary: $20 to $28 per hour based on qualifications.
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