Balloon In Line Quality Inspector

Interface Associates is an 11 year old, fast-growth medical machine and contract manufacturing company that provides solutions for catheter manufacturing.  Products include balloon forming machines, catheter assembly and test equipment, balloon development, and balloon contract manufacturing.  Plants are located in Laguna Niguel and Aliso Viejo, CA.  Significant profitable growth and recent cash infusion from investment partners, positions the company to go to the next level of performance.Summary Under general supervision and guidance, performs visual, dimensional, and functional inspections on a variety of products, specializing in high precision setup and inspection of stretched blow molded components (balloons). Works from inspection plans, following prescribed sampling plans, inspection methods, specifications, drawings and established standards. Reports nonconformance’s to Supervisor and discusses corrective action. Determines whether product is acceptable or rejectable, initiates rejection notices, and maintains accurate written records of the inspections performed, including the results. Recognizes conditions outside their specific areas of inspection which require action and refers the items to the supervisor. The position carries out work assignments that comply with company standards and Good Manufacturing Practices; and assures that procedures are complied with, product is properly handled, and proper records are maintained

 Essential Duties and Responsibilities 

§ Reads and interprets work orders to inspect product to specifications.  

§ Seeks assistance from work center leader/supervisor as required.

§ Ensures quality of product through application of knowledge and understanding of documentation.  

§ Performs diagnosis of condition of the product by performing a series of standard tests.

§ Demonstrates ability to read documentation in order to inspect any product in given functional area.  

§ Documents initial condition of product and components.  

§ Demonstrates knowledge of tools and equipment necessary to inspect product in functional area.  

§ Ensures tools are used and maintained in compliance with routers and test methods.  

§ Maintains accurate records of work performed and products inspected.

§ Identifies areas for improvement and recommends solutions to supervision.

§ Assists in training as assigned.

§ Identifies safety issues in the workplace and recommends solutions for improvement.

§ Maintains work area appropriately in the controlled area.

§ Completes necessary documentation thoroughly, accurately, and on time.

§ Ensures compliance with Quality System requirements.

§ Wears required Personal Protective Equipment as needed.

§ Performs other non-routine duties as assigned by Supervisor.

Education and Experience

o  High school diploma or general education degree (GED)

o  2-3+ years in a Quality Control role

o  Medical Device industry experience in balloon catheters