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Quality Systems Technician in Kenosha, WI at Tecomet

Date Posted: 11/28/2018

Job Snapshot

Job Description

Would you like to be part of cutting edge technology in the field of medical devices? Is being part of a team that makes a difference in people's lives important to you?  Then our Tecomet -Kenosha manufacturing plant, conveniently located between Chicago and Milwaukee, and within 1-2 miles of the expressway might be the right fit for you!

Tecomet, Inc. is a dynamic and growing  contract manufacturing organization specializing in forged, cast and machined orthopaedic implants, precision surgical instruments, sterilization cases/trays and photochemical etched products for the orthopaedic industry.   It is an exceptionally exciting time to join Tecomet as we grow our organization through the recruitment of great team member candidates.   It's not how we do it now today - it's how we do things in the future; let's all learn something new together and achieve our overall goals TOGETHER!

POSITION SUMMARY

This position will work closely with Quality Engineering and members of the CFT. The Quality Systems Technician will be responsible for maintenance and development of key quality systems as assigned.  The scope of the job will include supporting the setup of new products, product extensions and product revisions. This role will require day to day quality technical support such as creating and assisting with inspection criteria, control plans, FMEAs, labelling, customer complaints, tracking and trending, etc. The role may require responsibilities to be assigned/delegated between two Quality System Technicians.

PRINCIPAL RESPONSIBILITES

  • Assists Quality Engineers (Q.E.’s) with the development of control plans and FMEA’s.
  • Establishes inspection methods, criteria, harmonization, and measurement system analysis. 
  • Interprets engineering drawings and specifications in order to develop and maintain inspection criteria.
  • Completes first article inspection reports.
  • Interacts with the Customer to assure timely completion of required activities.
  • Participates in team meetings and provides updates on action items
  • Learns, understands, and applies task-specific computer applications associated with assigned duties.
  • Creates Master Labels for approval - internal and customer
  • Creates, maintains and reviews label requests
    • Prints labels as requested
    • Monitors and maintains labeling supplies
    • Participates in contract review when labels are required.
    • Communicates with customers who require remote label creation as needed for routine issues.
    • Assists with troubleshooting routine labeling issues.
  • Issues RMA’s when requested.
  • Establishes and maintains complaint files.
  • Oversees the complaint process to ensure timely closure.
  • Communicates complaint status and closure with customers.
  • Maintains the customer complaint log.
  • Ensures all closed complaints are scanned and filed.
  • Participates in quoting and contract review process for review of measurement capabilities.

  • Participates as team member for performing internal audits.
  • Assists with training activities.
  • Reviews customer requirements and verifies transfer to internal documentation.
  • Additional functions and requirements may be assigned by supervisors/managers as necessary.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:

  • Quality System Regulation and ISO13485 knowledge base.
  • Experience in the area of manufacturing operations.
  • Thorough knowledge of English and metric dimensioning.
  • Understanding of Gage R&R.
  • Knowledge of GD&T
  • Understand the importance of ISO and Quality System Requirements (QSR) in manufacturing environments.
  • Understand and implement continuous improvement techniques on projects.
  • Possess dexterity and preciseness required to operate gauges and testing equipment.
  • Ability to follow written and verbal instructions.
  • Commitment to the growth and continuous improvement of the company and its employees.
  • Participate in Quality improvement projects as necessary to support the company goals and strategic business plan.
  • Must be capable of making decisions and being assertive in a professional way, appropriate for a growing customer-focused and employee-sensitive business environment.
  • Must be professional, conscientious, responsible, dependable, flexible, and proficient with good work habits, close attention to detail, strong workmanship and a positive attitude.
  • Must also be able to work independently and be capable of meeting deadlines.
  • Computer literacy.
  • Problem solving skills.
  • Good oral and written communication skills

EDUCATION AND EXPERIENCE:

  • High school diploma or equivalent required
  • Degree desired but not required
  • ASQ Certification preferred
  • Minimum 2 - 3 years Quality Assurance experience preferred
  • Metrology-related experience desired