Manufacturing Assembler Job at Intellyk Inc in Mansfield

Desired:

• Minimum of one (1) years’ experience in manufacturing operations with medical devices.

• Knowledge and experience with GMP, ISO, FDA, and quality standards

• Experience with manufacturing documentation such as, but not limited to, Bill of Materials (BOM), shop orders, routers, and other relevant manufacturing documentation including the maintenance of manufacturing metrics.

• Experience in a Clean Room environment

• This position is responsible for the assembly, packaging, and other steps along the production line of various medical devices as required by clients. Adherence to Good Manufacturing Practices (GMP) and FDA, ISO, and environmental requirements.

• This position must adhere to safety guidelines and standards to ensure the products are properly assembled and packaged. 

• This role helps move a product towards the consumer market.

Essential Duties And Key Responsibilities:

• Accountable for the day-to-day manufacturing activities, which include but are not limited to:

• Work on the required manufacturing shop orders/work load

• Maintain appropriate training as required by the company

• Production accuracy and quality

• Accurately follow manufacturing procedures and quality standards

• Ensure that the proper material is available to perform the assigned manufacturing work

• As required, work with Engineering personnel to assist and develop process and equipment validation/qualification plans and protocols

• Assist/support in the execution of such plans, which include testing, data collection, etc.

• Provide problem solving support to the manufacturing operation as required

• Work closely with and play an integral role in the team building process with other cross-functional groups including, but not limited to, Quality Department and Development

• Other responsibilities as required

 Skills/Competencies:

• Read, write, and understand English

• Ability to understand documentation such as, but not limited to, Bill of Materials (BOM), shop orders, routers, and other relevant manufacturing documentation including the maintenance of manufacturing metrics.

• Ability to remain productive under indirect supervision and follow verbal and written instructions and techniques

• Ability to lift up 20 lbs.

• Basic mathematical aptitude required

Education And/or Experience Required:

• High School diploma, or equivalent