Quality Engineer

About the role

The Quality Engineer is responsible for supporting the manufacture of surgical instruments, translating customer requirements into effective inspection criteria, and delivering zero defects to the next process and customer.

Responsibilities

• Ensures cell processes are correctly baseline and controlled, accounting for known variability through inspection frequency, sampling plans, or SPC implementation.
• Develops and implements inspection/validation techniques to verify products meet requirements at the earliest point in the production process.
• Specifies the need for new inspection equipment and instructs others in its proper use. Obtains technical counsel to deploy the most accurate inspection methods and metrology.
• 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 may be required to train others in similar roles.

Requirements

• 4 Year / Bachelor Degree in Engineering or related field
• 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.
• Minimum 3-5 years' experience in quality with previous experience with CMM, optical measuring equipment, and metrology applied in machining applications.
• 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.

Qualifications

• Working knowledge of statistical analysis and methods required.

Skills

• Statistical analysis and methods
• CMM, optical measuring equipment, and metrology
• Blueprint reading and GD&T
• Supervisory or leadership experience
• CQT
• CQI

Benefits

N/A

Pay

$80,000 - $95,000 annually

Schedule

N/A