Job Description

Job Title:

Quality Engineer

Department:

Quality Assurance

Reports To:

QA/RA Manager

Location:

144 Railroad Drive, Ivyland, PA 18974

General Summary:

The Quality Engineer supports maintenance and improvements to the Quality Management System, production, product development, and other areas as needed.

Essential Functions:

Support the Quality Management System that establishes and maintains effective quality assurance processes and compliance to the International Standard: ISO13485, Canadian Medical Device Regulations (CMDR, SOR 98-292), and FDA Quality System Regulations (QSR, 21 CFR Part 820). Provide quality management system related reports to the company, pertaining to design, manufacturing, service, including statistical analysis of experimental, test, and quality data. Perform product failure investigations, design and conduct experiments and tests to develop a body of knowledge on components and product reliability. If applicable, initiate corrective or preventative actions. Facilitate site CAPA investigations and work with suppliers to address corrective actions and related activities. Periodically conduct product and process validations. Participate in supplier assessments and occasionally conduct an audit of suppliers. Perform analysis on mechanical and electrical assemblies. Clearly communicate any quality concerns to the Quality Assurance Manager. Uphold the Company Mission and Quality Policy. Other duties as assigned by management.

Skills and Attributes:

Strong interpersonal and communicative skills. Strong problem solving skills and root cause analysis experience using various analysis tools (FMEA, 5 Why, Fishbone, other). Electrical and mechanical troubleshooting skills. Technically inclined, ability to read schematics and drawings. Self-oriented, self-organized, and able to work with minimum supervision.

Education Required:

Bachelor of Science in the engineering field or equivalent and/or four years' experience in a quality role. Additionally, preferably two or more years' experience in a role related to medical devices.

Practical Experience:

Proficient in the use of a computer, Adobe, Microsoft Office tools including but not limited to Word, Excel, and PowerPoint.

Aptitude Required:

Mental: Constantly Mechanical: Occasionally Verbal: Constantly Personal Initiative: Very Important

Physical Requirements:

Standing: Occasionally Walking: Occasionally Sitting: Constantly Bending/Stooping/Squatting: Rarely Climb Stairs: Rarely Lying Down: Rarely Push or Pull: Rarely Reach Above Shoulders: Rarely Climb Ladders: Rarely Grasp/Grip: Rarely Finger Dexterity: Rarely Writing/Typing: Constantly Driving/Operating Equipment: Rarely Vision (Beyond Arms Length): Rarely

Lifting/Carrying:

Over 150 lbs: Rarely 76 - 150 lbs: Rarely 51 - 75 lbs: Rarely 26 - 50 lbs: Occasionally 10 - 25 lbs: Occasionally 1 - 9 lbs: Occasionally

Environment:

Hearing Requirements: Constantly Speaking Requirements: Constantly Working Indoors: Constantly Working Outdoors: Rarely Working in Confined Space: Rarely Exposure to Fumes, Chemicals, Solvents, Caustics, etc.: Occasionally Extreme Temperatures: Rarely Eye/Hand/Foot Coordination: Rarely

Reasoning Development:

Apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Deal with a variety of abstract and concrete variables.

Mathematics:

Add, Subtract, Multiply, Divide, and other as needed.

Reading:

Reads and able to interpret schematics, drawings, blueprints, standards, regulations, and other technical literature.

Writing:

Prepare business letters, expositions, summaries, and reports with proper format.

Speaking:

Speak clearly and distinctly with appropriate pauses and emphasis.

Job Type: Full-time

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Paid time off Vision insurance
Application Question(s):

What is your salary requirement?
Work Location: In person