Quality Engineer

Overview

Grace Medical, an Innovia Medical Company

Title:

Quality Engineer

Type of Position:
Full Time

Job Location:

Memphis, TN 38133

Innovia Medical combines the experience and expertise of Summit Medical, Network Medical, DTR, Eagle Labs, Grace Medical and Hurricane Medical to help our medical professional partners elevate the delivery of care to improve patient outcomes. We develop products not just for our customers, but with our customers. Our collaborative approach cultivates innovative medical solutions for the global healthcare industry. Through excellence in design, supply chain management, manufacturing and customer service we put quality at the forefront in all aspects of our business.

This is a full-time Quality Engineer position based on-site in Memphis, TN. The Quality Engineer will primarily be responsible for supporting the quality system and to ensure the compliance of the company’s quality management programs. To prevent or eliminate deviations in procedures and adherence to GMP requirements.

• Work with suppliers, management, and manufacturing associates in the resolution of product quality problems
• Investigate product complaints and reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements
• Develop or update company complaint and inspection procedures to ensure capture, investigation, and proper documentation
• Monitor risk-management procedures, and use problem logs to identify and report recurring issues to management and product development teams
• Responsible for employee training and support to Grace Medical, Inc.; focusing on systems, policies, procedures, and core processes
• Co-develop test requirements for company COPs
• Defines Quality Plans and Inspection methods. Review engineering changes for the impact on existing inspection plans
• Work with R&D on new product launches; including design reviews, input/output, risk management, and design V&V
• Create CAD generated inspection (DIT) Dimensional Inspection Templates (Solid Works)
• All other duties as assigned

• Minimum of five to seven years' experience with medical device company or related field.
• Knowledge of quality assurance terminology, methods, and tools
• Excellent analytical, problem-solving, and decision-making skills
• Demonstrated knowledge of testing best practices, version-control procedures, and defect management processes
• Professional certification, such as Six Sigma, CQE (certified quality engineer), or CQA (certified quality auditor) preferred
• Superb computer proficiency, including database management
• Demonstrates proficiencies in CAD generated inspection (DIT) Dimensional Inspection Templates in Solid Works preferred

Knowledge - Good computer and professional telephone skills and the ability to operate all required office equipment. Organizational, analytical and problem-solving skills are necessary. Must be able to speak English and possess expert level written and verbal communication skills.

Mental – Requires a relatively high degree of concentration and attention to detail and superior organization is a must. Proactive and able to work independently with excellent time management skills. Flexible attitude with ability to work under pressure and meet project deadlines. Commitment to quality approach to work in a team environment.

• Physical – Requires walking/standing approximately 5% of time; sitting approximately 95% of time; lifting up to 25 lbs. approximately 15% of time; stooping, forwarding bending and crouching approximately 5% of time. Sometimes requires standing eight hours a day at meetings and conventions. Must be able to travel.
• Environmental – Requires capability of performing essential job functions in an office environment with climate-control and good lighting
• Manual Dexterity – Requires use of hands and arms to operate telephones, facsimile machines, computers and other general office equipment, to record written information and maintain files.
• Audible – Requires the ability to verbally communicate with customers, distributors, vendors, suppliers, FDA/ISO/MDSAP auditors, and co-workers in person and via telephone.

* The above description is intended to describe the general content, identify the essential job functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of job functions or requirements.