Quality Technical/Production Lead

Description:

 

Under direction, administers, and coordinates the activities of manufacturing and quality in support of company policies, goals, and objectives established by the President and Operations Manager by performing duties personally or coordinating with all manufacturing personnel. This position requires supervising cleanroom staff within the cleanroom approximately 90% of the time.

 

Responsibilities:

 

Ensures that the responsibilities, authorities and accountability of manufacturing personnel are defined and understood.

 

Ensures manufacturing personnel are following all manufacturing/testing procedures as well as assembly and cleanroom operations.

 

Assists the Operations Manager in writing and revision of procedures, training production personnel, conducting and documenting failure investigations, ensuring equipment is calibrated, and the compilation and review of lot history records.

 

Contacts outside services for quotes and supplies, engineering needs and general information.

 

Performs various functions such as receiving, inspection, manufacturing, packaging, maintenance duties, cleanroom cleaning and other functions  as assigned.

 

Assists with maintaining inventory control.

 

Requirements:

 

Job entails working inside a class 7, medical device cleanroom environment and maintaining a quality working environment in accordance with established procedures.

 

Desired applicant is to have experience working in a medical device or pharmaceutical environment and posses documentation skills, verbal and written communication skills, organization skills and computer literacy in Word and Excel. The Quality Technical/Production Lead is to be attentive to detail, able to problem solve, improve processes, and have an understanding of Quality System Regulation (cGMPs) and basic manufacturing procedures, processes, and production equipment operation.