Quality Engineer

Quality Engineer

Profile Summary

• The candidate will establish and maintain the quality assurance program to ensure that the products and the quality system are in compliance with cGMP practices, ISO 13485 requirements and local government and company procedures. The candidate will also provide inter-departmental support by resolving quality issues in a timely manner, establishing and maintaining quality documentation, performing validations, participating in audits and facilitating continuous improvement initiatives.

Essential Duties and Responsibilities

Include the following. Other duties may be assigned. Provide resolutions to non-conformances resulting from internal and external processes.

• Perform validations (IQ, OQ, PQ) for infrastructure.
• Perform internal audits and facilitate second party and third party audits.
• Utilize problem solving techniques such as fishbone diagrams and 5-whys to assist the team in performing Root Cause investigations.
• Implement Preventive and Corrective Actions in a timely manner.
• Maintain and review Quality Metrics and KPIs. Perform trend analysis and identify action plans.
• Assist in the creation, review and approval of procedures, specifications, inspection plans and quality records.
• Communicate quality or compliance concerns with urgency.
• Assist the Quality Manager in processing rejects and returns by utilizing Epicor ERP.
• Collect data and execute/conduct various analytical/statistical analyses and interpretation as part of process improvements and day-to-day support.
• Assist the Quality Manager in training personnel.
• Report improvements to management and appropriate cross-functional teams.
• Teamwork is essential for continued success, so Teamwork is an essential function of every employee’s job. Teamwork drives positive results every day. Teamwork promotes positive customer relations and results in exceeding the expectations of our customers. Teamwork benefits every employee since it grows our business and increases our sales. With Teamwork, we all succeed. Without it, we all suffer. Teamwork with co-workers in the same department is just the beginning. Teamwork with every other employee, department and division is the Teamwork that is required to succeed.

Requirements

• Safety Training
• To perform this job successfully, an individual must complete and maintain the following Safety Training requirements.

1. General Safety Orientation

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

• Minimum of a BA/BS is required.
• A minimum of three years’ Quality Engineering experience in the Medical Device is required.
• A minimum of 3 years of GMP experience in an FDA/Health Canada/ISO regulated industry is required. Experience with statistical analysis, root cause problem solving, and validations is required.
• Ability to define problems, collect data, establish facts and draw valid conclusions is required.
• Energetic, with strong interpersonal, organizational and communication skills. Excellent verbal and written communication skills.
• Demonstrated ability to accomplish work goals.
• Must be able to interpret blueprints in accordance with ANSI Y14.5.
• Must have a strong knowledge of ISO 13485 and other quality systems.
• ASQ certification as a Quality Engineer is preferred.
• Cleanroom experience is preferred.

Language Skills

• Must possess the ability to express thoughts clearly, both verbally and in written context. Must have strong knowledge in working with the MS Office Suite.

Mathematical Skills

• An understanding of all basic mathematical skills.

Reasoning Ability

• Should be familiar with the different processes required to process materials through a manufacturing environment. This knowledge would help the individual to be able to install necessary inspection points throughout the manufacturing operations.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk and use hands to finger, handle, or feel. The employee is occasionally required to sit. The employee must frequently lift and/or move up to 50 – pounds. Specific vision abilities required by this job include close vision, peripheral vision, depth perception and ability to adjust focus. Must have the ability to travel for business purposes.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and environmental restrictions. The noise level in the work environment is usually moderate