Quality Engineer

Responsible to support the manufacture of surgical instruments, responsible for translating customer requirements into effective inspection criteria to be deployed by machine operators for the assurance of quality and delivering zero defects to the next process and customer.

Essential Duties and Responsibilities but not limited to:

Responsible for ensuring cell processes are correctly base lined & controlled. Known variabliity is to be accounted for through selection & frequency of inspection, sampling plans, or implementation of SPC.

Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point inthe production process.

Specifies need for new inspection equipment and instructs others in its proper use. Obtains technical counsel from Quality Manager to fully understand and interpret customer requirements so that the most accurate inspection methods and metrology are deployed.

Demonstrated technical leadership in support of Quality Inspectors.

Responsible for the audit and continuous improvement of operator quality in the pursuit of zero defects.

Performs and assists in developing corrective action responses for internal and external customers.

Investigates deviations, OOS, complaints, returns, recalls, and field-alerts.

Supports the Material Review Board (MRB) for internal non-conformances and customer returns.

Implements, monitors, and tracks progress of First Article Samples.

Works with Quality team to ensure the PVE type deliverables are completed per customer requirements.

Creates and supports ECNs and SCRs (product)

Provides new hire and on-going training to ensure requirements are met and enable cell quality technicians to increase their knowledge and skills.

Performs inspection duties, as required. Provide day-to-day oversight of quality including batch testing, inspection, calibration, environmental monitoring, qualification, document review, etc.

Interfaces with customers and suppliers at a professional level, as required.

Supports quality improvement and cost savings initiatives, as required.

Supports both internal and external audits of all corporate quality systems and demonstrate compliance through objective evidence.

May supervise employees.

Be able to meet the visual acuity requirements (shades of color and color blindness).

Assists in receiving and conducting receiving inspections on products from outside resources.

Assists the Sr Quality Engineer and/or Manager with other tasks, as assigned.

Leads or assists in multi-function continuous improvement activities as requested by the Quality Manager, including Gage R&R studies, training others in statistical techniques, and process control/validations.

Once employee demonstrates competency in position, he/she maybe required to train others in similar roles.

Education:

4 Year / Bachelor Degree in Engineering or related field

Experience:

3- 6 years experience with tight tolerance measurement systems in machining applications, blueprint reading, GD&T, and a working knowledge of short-run process control methods, DOE, ISO standards, FDA quality system regulations.

KSA's:

Working knowledge of statistical analysis and methods required.

Minimum 3-5 years' experience in quality with previous experience with CMM, optical measuring equipment, and metrology applied in machining applications.

Demonstrated ability and willingness to use AI tools to improve productivity, decision-making, work quality, and to reduce costs. The successful candidate must be able to identify appropriate AI use cases and critically evaluate AI-generated outputs.

Proficiency in blueprint reading and GD&T to include principles of quality engineering required.

Supervisory or leadership experience strongly preferred.

CQT strongly preferred.

CQI a plus.

Excellent interpersonal, scheduling, leadership, and technical quality skills required.

A strong work ethic with the ability to cultivate and maintain cooperation from others required.

Ability to work with minimal supervision and actively participate in a team-oriented manufacturing environment.

Proficient in use of various test equipment such as optical comparators, micrometers, calipers, gage blocks, pin gages, etc.