Quality Inspector - B Shift

SMC Ltd.•Amery, WI

About The Position

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people. Job Summary: Perform routine visual and dimensional inspections of received, in-process, and finished components, subassemblies, and device products to pre-defined dimensions and specifications. Monitor and verify inspection data in accordance with specifications, statistical process, or other control procedures. Provide effective communication regarding product quality status to manufacturing teams. Regular attendance with occasional overtime and other duties as assigned.

Requirements

High School Diploma or equivalent required.
Minimum of1year of experience in the manufacturing environment.
Knowledge and practical understanding of inspection methods and equipment.
Proficient with Microsoft Word and Excel.
Working knowledge of ISO, FDA, GMP, and OSHA standards preferred.
Ability to read, write and communicate in English.
ASQC certification preferred or other quality related courses.
Minimum of2years of experience in the plastics industry, clean room/medical device assembly.
Working experience with inspection methods and equipment.
Mechanically inclined, mathematics skills, basic knowledge of statistics.
Ability to read Blueprint and basic GDT tolerancing.
Some experience with an ERP system and Data entry.
ASQ certified or other formal training.
Minimum of 5years of experience in the plastics industry, clean room/medical device assembly.
Knowledge and experience of applicable Inspection methods and inspection equipment.
Proven knowledge of GDT or classes
Experience with an ERP system and Data entry
Ability to read, write and communicate in English.
Mechanically inclined, strong mathematics skills and knowledge of statistics.
Experience in Pharmaceutical Device manufacturing / drug handling
Class 7/ISO 10,000 Cleanroom experience
Critical attention to detail.
Demonstrate strong decision-making abilities.
Proficient knowledge of Good Documentation and Good Manufacturing Practices.
Proficient use of the ERP system.

Nice To Haves

Working knowledge of ISO, FDA, GMP, and OSHA standards preferred.
ASQC certification preferred or other quality related courses.

Responsibilities

Perform with basic blueprint reading and understanding of tolerances.
Perform Visual Inspections with guidance on decision making.
Accurately perform basic mechanical Inspections utilizing some equipment.
Able to effectively run CMM/VMM programs.
Identify Out of Tolerance and unacceptable conditions.
Initiate MRB and perform proper containment.
Complete inspection data entry with minimal errors.
Completion of Product Release Checklist
Basic navigation of ERP system.
Perform effective Blueprint reading, tolerances, and basic GDT understanding.
Perform Visual Inspections and proper decision making.
Accurately perform mechanical Inspections with all equipment.
Ability to calibrate CMM tips and execute CMM/VMM programs.
Ability to perform basic trouble shooting and re-start and shutdown of equipment.
Initiate MRB and perform proper containment.
Complete inspection data entry with accuracy and no errors.
Effectively communicate and problem solve with manufacturing team.
Mid-level knowledge of ERP system.
Capable to perform basic Direct data import.
Must be cross trained in at least 1additionalmanufacturing area.
Perform accurate review and closure of BHR & DHR’s
Perform re-inspections of Rework with oversight.
Perform as GRR Operator with minimal oversight from Metrology.
Perform as back up for Receiving Inspection.
Completion of Product Release Checklist
Aide in training Level I Inspectors.
Perform proficient Blueprint reading and GDT application.
Perform Inspections in all Manufacturing areas.
Perform calibration of CMM tips, set up, recognize inaccuracies and quality issues.
Problem solve inspection equipment and program issues for inaccuracies or poor performance.
Initiate MRB’s, properly contain product for any nonconforming product and complex situations which involve other locations and item numbers.
Complete inspection data entry with high level accuracy and overview of other entries
Perform direct data import and problem solve concerns.
Proficient use of the ERP system.
Train level I and level II Inspectors.
Work with Production, Engineering on problem solving and investigations related to quality.
Aide metrology with GRR, bias studies, capability studies.
Aide in Continuous Improvement areas.
Conduct calibration of quality equipment on a limited basis.
Demonstrate strong decision-making abilities.
Responsible for verifications of rework activities independently
Perform accurate review and closure of BHR & DHR’s
Perform incoming receiving inspection of pharmaceutical products ensuring accuracy of paperwork and physical sampling.
Perform in-process and product testing inspections with attention to critical accuracy of data entry through either manual or direct data import actions.
Initiate MRB’s, properly contain product for any nonconformances.
Perform accurate review and closure of BHR & DHR’s, including yield, reconciliation, and OOS.
Responsible for verifications of rework activities independently.
Problem solves inspection equipment and program issues for inaccuracies or poor performance.