Responsible in performing quality control and assurance of extrusion products, incoming materials, sub-assemblies, and finished products within the organization.
Responsible in maintaining the material inventory program of released materials, components, sub-assemblies, and finished products in the stock room.
KEY RESPONSIBILITIES:
Ensures that all documentation is available and in order prior to any product related inspection activity.
Ensures the observance of the Line Clearance at all times during inspection activities.
Liaises with R&D, Extrusion, and Production to ascertain work priority on a daily or weekly basis.
Inspects materials, components, and products in accordance to defined procedures, product specifications, and technical drawings.
Ensures MRB cage is in order and adequately managed.
Manages the QC Lab and QC Inspector(s) in daily routine activities.
Performs random audits of production line(s) to ensure compliance with relevant procedures.
Maintains cleanliness of the work environment by adhering to relevant Standard Operation Procedures (SOP).
Confers with the QA management(s) relating to any process improvement in inspection techniques and methodologies.
Identifies areas for the need of fixtures to facilitate ease and economy in inspection.
Assists in problem solving, root cause analysis, and corrective action when required.
Participates in Gage R & R testing of developing, maintaining, and enhancing test methods.
Assists with training and instruction for production operators in QA measuring procedures and methods.
Attends project meetings, quality related meetings, and company- wide meetings as directed by management.
Maintains product and company reputation by complying with Quality Systems Regulation (QSR), Quality Management Systems (QMS), and other government regulations.
Reports to quality management any equipment malfunction observed in the inspection area.
Assists quality management in maintaining the integrity of the quality system of the organization.
Ensures that material stock information is always updated to provide adequate information of the material inventory level.
Contributes to team effort by accomplishing related results as needed.
SKILLS/QUALIFICATIONS
Minimum of High School diploma (some college units is a plus); Minimum of three (3) years of QA related inspection in medical device industry; Able to read technical drawings or prints and use pieces of hand-held test equipment; Knowledge of sampling plans (Zero Sampling Plan, ANSI/ASQ Z1.4 and Z1.9); Experienced with smart scope, borescope, and other vision system; Basic knowledge of cGMP; Computer literate. Can handle multi-tasking activities; Team player; Can communicate effectively at all levels of the organization: Can read and write English; Can lift up to 20 lbs.
