Quality Control Technician II Summary: Conduct Quality audits of production facilities assuring company standards are maintained and product integrity is preserved. Consult with management to resolve quality, production, and efficiency problems. Function as an information source to various company departments when special and critical quality issues occur. Function in conjunction with Manager, Quality Services on special department projects. This position description/summary reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. The Core Principles embraced:
- Engaged Employees: All employees have an obligation to understand; who we are, why we are here and where we are going.
- Customer Driven: Everything we do is driven by our passion to support our customers.
- Results Oriented: Good intentions and taking action aren’t enough – we need to get results
- Respectful Communications: It is okay to disagree – it is not okay to be disagreeable
- Fairness: We will be fair in our dealings with each other, our customers and suppliers, and our communities.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Educate and instruct plant personnel in recommended quality control testing and equipment methods.
- Function as an information source for production, and other departments when critical quality issues arise.
- Perform first article, may occasionally perform first piece and in-process reviews as well as final and priority as assigned by QA Manager or QA Lead.
- May process shipping paperwork. This includes preparation of Shipping paperwork packages and/or review of shipping package (per customer requirements) submitted by QA Technicians. If assigned by QA Manager or QA Leader, prepare the Customer paperwork shipping package.
- Assist in development of special department projects and work in conjunction with Manager, Quality Services.
- Accept responsibility of training and preparing new employees for this position.
- Process non-conforming material, reporting data, involving in disposition of material
- Perform other duties as directed by QA Leader or QA Manager
- Interprets engineering drawings, schematic diagrams, or formulas and confers with management or engineering staff to determine quality and reliability standards.
- Selects products for tests at specified stages in production process, and tests products for variety of qualities such as dimensions, performance, and mechanical, electrical, or chemical characteristics.
- Records test data, applying statistical quality control procedures.
- Evaluates data and writes reports to validate or indicate deviations from existing standards.
- Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.
- Sets up and performs destructive and nondestructive tests on materials, parts, or products to measure performance, life, or material characteristics.
- Prepares graphs or charts of data or enters data into computer for analysis.
- Maintain calibration system to ensure all measuring equipment and process equipment is calibrated.
- Program and Operate CAM/Vision system.
- Recommends modifications of existing quality or production procedures to achieve optimum quality within limits of equipment capability.
- Sets up, program, and operate CMM/Vision system.
- Assist in developing Inspection plans.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
Associates Degree or higher in a related engineering and or technical discipline. 2 to 5 years’ experience or equivalent combination of education and experience working in FDA medical device and ISO 13485 regulated environment. Internal Auditor experience is a plus.
Ability to read and interpret documents such as safety rules, purchase orders, vendor acknowledgements, manufactures catalogs, maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with Vendors and groups of employees of organization.
Knowledge of ISO 9000 /ISO 13485 quality management systems and proficient use of Microsoft products – specifically Microsoft Excel
Job Type: Full-time
Salary: $23.00 to $28.00 /hour
- PC-DMIS software: 2 years (Preferred)
- Brown and Sharpe: 2 years (Preferred)
- CMM: 3 years (Preferred)
- Quality Audit: 3 years (Preferred)
- ISO 13785: 1 year (Preferred)
- 1st Piece Inspection: 3 years (Preferred)