Quality Technician II (Days)

Job Description

Title: Quality Technician II

Reports to : Quality Technician III/ Technical Group Lead

Schedule: 5AM to 3:30PM, Monday - Friday

Pay: $21.94/hr. (competitive pay) based on experience, skills and track record of success

Benefits: Full time associates are eligible for benefits the first of the month following 30 days of service.

• • Medical Insurance
    • HDHP, HSA Plan - Employer Contribution of $1,040/yr.
    • High PPO
    • Low PPO
    • FSA
  • Dental Insurance
  • Vision Insurance
  • Employer Paid Basic Life Insurance
  • Supplemental Life Insurance
  • Employer Paid Short Term Disability
  • Long Term Disability
  • 401(k) 4% Employer Match
  • Paid Time Off (accrued hours, 120/ year)*
  • 9 Paid Holidays
  • Continuing Education and Seminar Programs
  • EAP Program
  • Fitness Room

Summary: Primary duties of this position will be to work from engineering drawings, work instructions and other established specifications to determine acceptance, rejection or rework requirements of product within company directives and operating procedures consistent with FDA, GMP, ISO 9001 and ISO 13485 guidelines. The Quality Technician II will have extensive experience in the setup, adjustment, alignment as well as a demonstrated ability to safely run complex inspection equipment. The Technician will perform visual and dimensional inspections using visual standards and inspection tools including programmable Coordinate Measuring Machines (CMM). They will create and run measuring programs using CMM software. They will use procedures including sampling plans to conduct component and assembly inspections. The Quality Technician II will also collect and analyze data using spreadsheet software programs.

Duties/Responsibilities include but are not limited to:

• Performs tooling inspections.
• Performs first piece and product inspections as necessary for all Value Streams.
• Provides traceable verification by completing inspection documentation or other documents for all components, assemblies, and/or product lots inspected, as required by inspection documentation.
• Performs evaluation of returned goods to verify assembly integrity as requested by the Material Review Board (MRB).
• Maintains control of documentation, tools and product within the inspection work space.
• Provides training and feedback to associates in quality practices, acceptance criteria and measurement technique.
• Identifies process discrepancies and communicates them to appropriate advisors.
• Prepares necessary reports including documenting test results and statistics.
• Assists in the development of training for visual inspection.
• Maintains electronic inspection data using established procedures and file naming conventions.
• Retains records according to company policy and samples from inspections.
• Places equipment or product on hold when inspection records indicate product or equipment operation is found to be not capable of producing acceptable output.
• Trains others as needed in GD&T and quality practices.
• Participates in team meetings as required.
• Wears personal protective equipment as required.
• Maintains a clean work area and utilizes safe working practices.
• Performs all activities in compliance with Quality System requirements.
• Acts as a resource to Estimating/Planning and Engineering for the development of tooling as necessary.
• Acts as a resource for quality practices for all Value Streams.
• Creates complex programs as needed for the Coordinate Measuring Machines

Accountabilities:

• Positively contributes to achieve company's safety goals.
• Accountable to achieve team quality goals.
• Accountable for tooling and accurate first article inspections.
• Accountable to achieve goal for continuous process improvement of the inspection process.
• Accountable to achieve quarterly goal for accurate electronic and hardcopy inspection data.
• Accountable for maintaining current learning and development as required for position and training others in GD&T and quality practices.
• Accountable for completing calibration of in-house hand-held devices.

Training/Education/Experience:

• High School diploma minimum.
• Post secondary education in a technical program preferred.
• 5-7 years of related experience in a manufacturing environment; medical device industry experience a plus.
• Formal training or experience with Lean manufacturing principles.
• Proficient using Microsoft office.
• Minitab experience required.
• Trained in FDA GMP and/or ISO 9001 and ISO 13485 guidelines.
• ASQ Certified Quality Technician or Certified Quality Technician certification a plus.

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

• Excellent communication and writing skills.
• Exhibits a professional demeanor at all times.
• Ability to read and understand verbal and written instructions.
• Ability to read and interpret complex engineering drawings and specifications.
• Advanced understanding of geometric dimensioning and tolerances.
• Identify process/product non-conformances or borderline quality conditions that may require corrective action.
• Working knowledge of inspection sampling plans (i.e., ANSI C=0).
• Excellent hand/eye coordination, manual dexterity, and vision.
• Detail oriented.
• Advanced working knowledge of quality control dimensional inspection tools such as Calipers, Micrometers and the programming and operation of Coordinate Measuring Machines.
• Can speak, understand and write English.

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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