Medical Device Company seeks experienced Quality Engineer.  The Quality Engineer is responsible for quality planning and continuous improvement working closely with manufacturing suppliers and the design team to reduce defects and improve product quality.   The Quality Engineer is responsible to perform failure mode and effects analysis, process control plans, work instructions, corrective and preventative actions.

RESPONSIBILITIES

Manage day-to-day quality concerns across process, products and service of manufacturing suppliers

Understand quality control in supplier manufacturing operations

Conduct routine and non-routine analysis of raw materials, in-process and finished goods

Perform training, audits, reports and procedures regarding quality planning and quality control

Perform analysis on product returns using statistical problem solving techniques, coordinate field corrections and reports all adverse events

Review supplier documentation and perform supplier audits on process and materials

Work with product technical team on product design and process capability

Review technical change requests and impact on product and process

Review quality planning & control documents including; SOP, Control Plans, CAPA, FMEA, First Article, and participate in DFMEA development

REQUIREMENTS

BS in Engineering – ME/EE/IE/Bio-Medical or Science Degree

5-7 years quality experience with medical device

FDA inspection experience in the medical device industry

Working knowledge of ISO13485

Quality planning, statistical process control, analytical tools, etc.

Understand and manage potential issues and resolve them with integrity

Multi-task under pressure

Hands on approach to problem solving

Ability to read and understand government and industry standards, product specifications, and blueprints; examples are FDA and ASTM

Excellent verbal and written communication skills with both internal and external customers/suppliers

Proficient computer skills (MS Office Suite)

PREFERRED QUALIFICATIONS

Class 1 and or Class 2 experience

CQE, CQA or other quality certification