Quality Control Supervisor

7 days ago

Ontario, United States Stevanato Group Full time

***Position will oversee 3 shifts in a 24/7 working facility***

1st - 6:00 am to 2:30 pm

2nd - 2:00pm to 10:30 pm

3rd - 10:00 pm to 6:30 am


Job Summary:

The primary purpose of the Quality Control Supervisor is to coordinate activities and provide daily direction to quality team members to ensure that quality requirements, performance goals and improvement objectives are achieved. In addition, this role will develop process improvements and identify deficiencies in processes or systems that enable the department to execute at a more accurate and efficient level.

This role will work with production to ensure that efforts are aligned and will manage the day-to-day processes around performance management and attendance for each individual in the department. Moreover, they will be responsible for performing/overseeing inspecting, monitoring and releasing to established acceptance criteria, metrology, calibrations, troubleshooting and scheduling of preventive maintenance and services for the Quality Control Department. Key involvement in problem solving related to measurement outcomes and processes.


Essential Job Functions and Responsibilities:

  • Manage daily performance and attendance of QC Inspector & Metrology personnel in the inspection and final release of sub-component parts and finished goods. Provide work direction and guidance throughout the shift on issues relating to Quality, schedule attainment and metrology.
  • Supervises Associates in a manner that fosters a safe work environment and self-directed team approach.
  • Provides leadership to Associates in all areas including: hiring, performance management, coaching, counseling, and corrective actions while promotes an atmosphere of diversity, open communication and trust, affording opportunities for training and growth.
  • Identifies, arranges and/or provides training to ensure a safe, efficient, quality work environment with focus on continuous improvement through Lean manufacturing principles.
  • Monitor/track QA/QC department metrics and develop continuous improvement plans that drive site improvements. Maintain cleanliness of QC lab, implement and sustain Lean fundamentals including 6S, and speak to status of site Quality metrics.
  • Able to successfully program and update routines on automated systems (CMM, Keyence, Smartscope etc).
  • Oversee/Conduct First article, In process and final inspection (AQL) of manufacturing and assembly processes through visual inspections, Blueprint reading, SPC entry, usage of manual measurement tools, and automated systems (CMM, Keyence, Smartscope etc).
  • Actively participate and lead in Gage Repeatability and Reproducibility (GR&R), Geometric Dimensioning and Tolerancing (GD&T or GD and T) Intermedium studies and product/process validations (IQ/OQ/PQ), performs metrology activities, drafts and issues metrology reports following completion of activities.
  • Able to conduct full FA Inspection & full layouts on part components
  • Review and actively participate with all product non-conformances and determine necessary corrective actions in conjunction with MRB team. Participate in Material Review Board activities and support Quality Engineering and Manufacturing Engineering in the resolution of non-conforming materials.
  • Performs basic repair and calibration of test equipment, such as micrometers and calipers, and develops new gauges and testing methods including the design and building of measurement fixtures to meet testing needs.
  • Assure that the analytical equipment is in good working order and that calibration and maintenance activities are executed on schedule.
  • Conduct necessary training on analytical instrument operation and maintenance for laboratory personal.
  • Responsible for maintaining document traceability analysis of engineering requirements, ISO documents related to part measurement, and training others within department as needed.
  • Prepare/revise SOP’s.
  • Helps in the identification of the magnitude of error sources contributing to uncertainty of results to determine reliability of measurement process.
  • Participation in the recommendation and purchasing of equipment as well as participation in product development activities by assessing and recommending measurement needs and techniques.
  • Oversee, quarantine cage and disposition materials as required.
  • Other projects and tasks as assigned.


Knowledge, Skills, and Abilities

  • Read and write in the English language.
  • Must be able to perform basic math such as addition, subtraction, multiplication, division, fractions, and decimals.
  • Ability to read and interpret basic engineering drawings and product specifications.
  • Experience with PCDMIS and Measuremind 3D automated inspection software usage (CMM, Keyence, Smart scope, etc.) and programming a plus
  • Knowledge of Medical device standards and Regulations (ISO 13485)
  • Auditing training and experience preferred
  • Knowledgeable and Proficient in the use of Coordinate and Vision Measurement devices like CMM, OGP, and Keyence. Required understanding of the proper use of standard measurement gaging like Optical Comparator, Mics, Calipers, Height Gages, and hard gaging
  • Experience writing SOP’s and reviewing IQ/OQ/PQ document and supporting process validation activities including testing and Gage R&R
  • Ability to identify and troubleshoot instrument problems.
  • Requires excellent communication skills, commitment and motivation, and a basic understanding of statistical techniques and analysis.
  • Ability to perform standard measurement and test equipment.
  • Comprehensive knowledge in blue print reading and interpretation and ANSI sampling plans.
  • Ability to interpret SPC charts.
  • Computer literate. Good verbal and written communication skills.
  • Desired candidate will have prior work history in MSA, SPC, Mini-tab, Infinity, & clean room environment.
  • Experience with handling non-conforming material
  • Experience with device history record creation and review
  • Knowledge of ERP and quality system elements
  • Experience with handling non-conforming material
  • Proficiency in using Microsoft Excel, Access Database and Word
  • Experience in supporting process validation activities including testing and Gage R&R
  • Understands how to interpret drawings, specifications, and other customer requirement documents.
  • Understands metrology and the use of metrology tools


Education and/or Experience:

  • Associates Degree or equivalent in related discipline with at least 5 years of prior QA/QC Supervisory experience in a manufacturing environment preferred; medical device experience preferred.
  • Preferred, Bachelor Degree or equivalent in related discipline with at least 4 years of prior QA/QC Supervisory experience in a manufacturing environment preferred; medical device experience preferred.
  • Desired candidate will have ASQ - CQI, CQT, lean certification and Leadership experience.
  • Working knowledge and application of ISO 13485 and FDA 21 CFR Part 820 quality system requirements. Inclusive of Good Manufacturing Practices and Good Documentation Practices.

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