JOB TITLE: Specialist

DEPARTMENT: Royalton Operations – Molding Production

REPORTS TO: Team Leader

DESCRIPTION:

Provides production and quality support to manufacturing of components and assemblies. Performs operator and material handling duties while providing periodic machine and quality part inspections. This position has the direct responsibility to ensure that all product manufactured, packaged, labeled, and shipped to our customer conforms to medical GMP and all the established Quality Assurance Requirements and General Appearance Samples. If product does not meet the established requirements, the Specialist shall document it and communicate it to the Quality Assurance Technician, Team Leader, and/or Process Technician.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

· Support molding and perform assembly operations while meeting stringent quality and throughput requirements

· Perform startup verifications: line clearance, review MIR forms, control lot assignments and print associated labels.

· Audit each assigned machine or Secondary process per the QAR to ensure the parts meet the customer’s specification & GAS requirements. These inspections will be documented.

· Read and follow all instructions on the Quality Assurance Requirements document (QAR).

· Communicate out of specification conditions to the Team Leader, Quality Assurance Technician or Process Technician

· Visually inspect product to the requirements as specified on the QAR and the General Appearance Samples (GAS) and other posted instructions and document on Attribute Tally Sheets.

· Interface with production, planning and quality to ensure efficient communication and resolution of problems.

· Document all quality related issues, events, problems using the quality communication log and/or Scorecard.

· Communicate machine and/or process problems to the Process Technician, QAT and/or Team Leader.

· Follow company safety rules, procedures, and policies and maintain a clean and orderly work area.

· Perform daily maintenance and cleaning activities as required.

· Support the “5’s” A place for everything and everything in its place program.

· Strive to be a contributing and supportive member of our team.

· Display a cooperative and positive attitude toward your teammates.

· Must have the flexibility to work additional hours and weekends when necessary.

· Must be able to lift up to 40 pounds.

QUALIFICATIONS:

To perform this job successfully, an individual must possess good organizational and detail orientation skills; be comfortable working in a manual, fast-paced manufacturing/assembly environment; and be able to understand and follow QAR and Control Plans.

· Previous medical device assembly and/or quality control experience is highly desirable.

· Prior injection molding experience is desirable.

· Prior manufacturing experience is desirable.

· Must have the ability to read and interpret documents such as safety rules, written instructions, and operating procedures.

· Written communications skills are a must, as this position requires that detailed documentation of each production run be properly recorded.

· Must have effective verbal and written communication skills in order to communicate problems and issues to the appropriate personnel, provide written shift turnover reports, and adequately relay concerns.