Quality Technician II - (Day Shift & Weekend Shift)

Job Description

Title: Quality Technician II

Reports To: Quality Engineering Manager

Schedule :

Day Shift/ Mon - Fri, 7AM - 3:30PM, (5 days, 8hrs)

Weekend Shift/ Friday - Sunday, 5AM - 5:30PM (12hrs, 3 days)

Pay: $22+/ hr

Summary: Proficient in measurement equipment set-up, adjustment, and alignment as well as a demonstrated ability to create programs and develop work instructions for visual inspections. Able to support training within the organization for GD&T and Inspection requirements. Participates in development of tooling and inspection methods. Works with Customer Focused Teams, and Production Focused Teams to create and execute inspection programs and related documentation. Supports and executes Test Method Validation for inspections per Test Method Validation Protocols under the direction of the Level III or Lead Technician. May participate in investigation of product and process issues utilizing problem solving skills to identify issues and actions required. Is able to work more independently with some oversight.

Duties/Responsibilities include but are not limited to:

• Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner.
• Meets commitments on time with accuracy and attention to detail.
• Maintains current knowledge base of applicable medical device regulations (FDA QSR, ISO 13485, ISO14971) and other associated standards or guidance documents.
• Based on assignment, will perform the following activities:
  • Set-up, adjust, align, and run complex inspection equipment including Coordinate measuring machines (CMM).
  • Conduct component first piece, and assembly inspections per inspection documentation which includes visual and dimensional inspections using standards and inspection tools
  • Collect and analyze data using software programs
  • Calibrate equipment
  • Identify, create and triage nonconformances and document in Epicor according to company procedures
  • Perform evaluation of returned goods

• Creates and runs CMM programs
• Performs inspection per documented inspection plans and test methods.
• Develops control plans and inspection methods from estimates, engineering drawings and other specifications to determine acceptance and rejection criteria
• Supports failure investigations
• Participates in continuous improvement and Lean initiatives
• Performs other related duties as assigned by management.
• Participates in the development and conduct of training for visual and dimensional inspections. Supports other Quality training as assigned.
• Assists with equipment and method qualifications

Training/Education/Experience

• High school diploma required
• Technical program certification (e.g. ASQ-CQT) or Associates Degree in Quality Technology preferred
• Proficient with Microsoft office software, especially Excel and Word. Computer skilled and able to learn Quality Software Systems including Epicor and Master Control.
• Ability to read and interpret basic to moderately complex engineering drawings and specifications
• Familiarity with inspection tools including CMM type equipment
• Understanding of GD&T principles

Quality Technician Experience:

At least 2-years as a QT 1, or equivalent experience, or ASQ-CQT with 1-years' experience as a QT 1

Physical Requirements:

• Vision correctable to 20/20 with normal color vision (where inspection criteria requires color discernment)
• Technical aptitude to work with equipment and inspection tools including but not limited to calipers, microscopes, and CMM type equipment
• Regularly required to sit as well as climb or balance, stoop, kneel and crouch.
• Must be able to work in manufacturing environments exposed to moving mechanical parts and restricted gowning requirements.
• Must occasionally lift and/or move up to 25 pounds.

Competencies/Talents/Personal Attributes

• Well-developed written and verbal communication skills in English. Ability to effectively present information to all levels within the organization, regulators, and customers
• Results oriented, self-starter, who can simultaneously work independently and as a high-performance-team member
• Strong attention to detail
• Very organized and able to maintain organized records
• Proficient with Microsoft Office software and familiar with CMM program execution and programming and GD&T software (SmartProfile, Measure-Fit)
• Able to create graphs and tabulate data
• Ability to prioritize and drive multiple activities and adapt to changing business needs;

• High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal supervision.

• Able to explain complex/technical matters
• Technical aptitude to work with equipment and tools including measurement equipment such as calipers, microscopes, and test equipment.

Notes: This Job Description is intended to be an accurate reflection of the current job as of the document effective date. This job description is not intended to be an exhaustive list of all required skills, duties, responsibilities, or qualifications associated with the positions described herein. The company reserves the right to revise or amend the qualifications, functions and duties of the jobs or to require that additional or different tasks be performed if business circumstances change. Employees are held accountable for performing the duties of their position, as evaluated by documented scorecards and performance management reviews based upon company specified metrics and goals documented in the scorecard for which the employee is made aware and maintains.

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