Quality & Manufacturing Engineer

CAIRA; New York (NY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life and disability insurance

Paid time off for vacation and federal

Employee Stock Option Program

Job summary

Caira Surgical is seeking a Quality & Manufacturing Engineer to lead the implementation and ongoing improvement of the company’s Quality System within a hybrid remote environment. The role collaborates with internal teams and external QA consultants to ensure FDA compliance and to onboard new suppliers in support of the supply chain.

The position emphasizes developing SOPs, coordinating across functions, and driving milestones and budgets while traveling about 20% of the time to support future

Qualifications

• Minimum five years of experience in medical device quality systems and compliance, preferably in the surgical navigation and robotics space.
• B.S. in engineering or related discipline.
• Supply chain experience in electronic medical devices is preferred.
• Project Management certification (PMP) preferred.

Responsibilities

• Develop expertise with the company’s Quality System, documents, and procedures.
• Develop expertise with the company’s supply chain partners, including material and component suppliers, PCB fabrication and product assembly vendors.
• Interact with various Quality consultants as needed.
• Drive the ongoing evolution of the Quality System, supporting regulatory guidelines and requirements for submission and clearance in the U.S. and OUS markets.
• Develop and execute a Quality Implementation Roadmap aligned with the company’s Quality strategy and business goals.
• Track project milestones and communicate implementation status using project management tools.
• Monitor compliance with the Quality System across the organization and collaborate with the Leadership Team to ensure compliance.
• Collaborate with all levels of stakeholders to establish objectives, timelines, milestones, and budgets for the Quality function.
• Prioritize tasks and handle a diverse workload while traveling approximately 20% of the time.

Skills

Communication skills

Team collaboration

Process improvement

Education

B.S. in Engineering

PMP certification

Tools

Project management software

Job description

Caira Surgical is recruiting for a Quality & Manufacturing Engineer. The position is hybrid remote.

Caira is a leading-edge MedTech innovator developing new technologies to improve navigated and robotic orthopedic surgery. The company’s mission is to create and commercialize technologies that improve patient care and surgical outcomes through increasing healthcare access, equity and quality of life for people worldwide.

The Quality & Manufacturing Engineer will work with internal colleagues and outside QA consulting resources to coordinate and execute implementation of the company’s FDA compliant Quality System across the organization. This position is also responsible for the continued development and maintenance of the company’s supply chain, including identifying, qualifying, and onboarding new suppliers and vendors supporting Caira’s supply chain in accordance with the company’s Quality System.

In close coordination with the Caira Leadership Team, the Quality & Manufacturing Engineer is responsible for standing-up the company’s Quality System, including collaboration with various functions and stakeholders (internal and external) to develop and implement SOP’s that accomplish compliance and organization-wide implementation of the Caira Quality System to support the company’s overall business goals.

Principal Duties and Responsibilities:

• The Quality & Manufacturing Engineer is responsible for developing expertise with the company’s Quality System, documents, and procedures.
• Develop expertise with the company’s supply chain partners, including material and component suppliers, PCB fabrication and product assembly vendors.
• Interact with various Quality consultants as needed.
• Driving the ongoing evolution of the Quality System, supporting regulatory guidelines and requirements for submission and clearance in the U.S. and O.U.S. markets
• Development and execution a of a Quality Implementation Roadmap and program that is aligned with the company’s overall Quality strategy and business goals.
• Track project milestones and clearly communicate implementation status using established project management tools.
• Monitor compliance with the Quality System across the organization and work collaboratively with the Caira Leadership Team and functional leaders to ensure compliance.
• Collaborate with all levels of stakeholders to establish objectives, timelines, milestones, and budgets for the Quality function.
• Prioritize tasks and handle a diverse workload while traveling approximately 20% of the time. Travel requirements may be impacted by the opening of future Caira locations.

Expected Areas of Competence

• Ability to work within a remote team environment and build strong working relationships across the company and diverse geography.
• Must be familiar with all aspects and elements of the implementation and management of quality system projects in a highly regulated environment. Experience with electronic medical devices is preferred.
• Ability and enthusiasm for thriving on a team in a fast-paced, highly innovative start-up environment in which work is assessed by outcomes and opportunities to make significant contributions are many.
• Demonstrated technical expertise and a strong sense of initiative and ownership.
• Ability to work with minimum supervision and formulate and evaluate options to complete work and meet objectives.
• Excellent communication skills (both oral and written), and ability to work with employees at all levels of the organization.
• Proficient with various software applications, including project management, record keeping, and routine database activity, word processing, spreadsheet, etc.

Education/Experience Requirements

• B.S. in engineering or an alternative bachelor’s degree in a related discipline.
• Minimum five (5) years of experience in medical device quality systems and compliance, preferably in the surgical navigation and robotics space.
• Supply chain experience in electronic medical devices, including PCB fabrication, component sourcing and product assembly is preferred.
• Project Management certification preferred (e.g., PMP).

Travel Requirements

• Up to 20%

Additional Information

Caira is committed to creating an environment where every team member feels included, respected, and empowered. The company is committed to recruiting high caliber candidates and offers a highly competitive benefits package that includes medical, dental, vision, life and disability insurance, paid time off for vacation and holidays, and participation in an Employee Stock Option Program.

• medical, dental, vision, life and disability insurance
• paid time off for vacation and holidays
• participation in an Employee Stock Option Program.