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Supplier Quality Engineer (Med Device) in Kenosha, WI at Tecomet

Date Posted: 12/8/2018

Job Snapshot

Job Description

FULL-TIME POSITION WITH IMMEDIATE HEALTH INSURANCE--NO WAITING!  GENEROUS COMPENSATION PACKAGE!

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

The Supplier Quality Engineer is responsible for managing supplier quality, and leader of the CAPA program for supplier non-conformances. Coordinates and drives improvements in quality, cost, and delivery.  Extensive knowledge of quality system requirements ISO 13485 & CFR 820.  Relies on experience and judgment to plan and accomplish goals.  Works independently with minimal supervision.

PRINCIPAL RESPONSIBILITES

  • Coordinates with suppliers and identifies areas for supplier quality improvements.
  • Determines gauging requirements and assists in measurement harmonization activities.
  • Leader of supplier CAPA program; reviews corrective actions and follow through.
  • Reviews and dispositions nonconforming materials.
  • Performs supplier audits to ensure quality compliance.
  • Develops and implements a supplier approval process.
  • Monitors suppliers through issuance of supplier rating reports.
  • Assists in contract/order reviews.
  • Leads efforts to reduce supply base in coordination with other Teleflex facilities.
  • Reviews and dispositions nonconforming materials.
  • Travel required up to 50%
  • Participates in design review for the purpose of gauging needs and meeting inspection criteria.
  • Assists with FMEA’s and Control Plans
  • Performs internal audits to ensure quality compliance.
  • Assists in other Quality Engineering duties as needed.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

  • Regulatory cGMP, QSR and ISO knowledge base
  • Computer literate/proficient with Microsoft Office applications
  • Negotiation and problem solving skills
  • Good oral and written communication skills; ability to properly speak and write in the English language
  • Math aptitude: strong statistical skills required (DOE, SPC, Reliability, Gage R&R)
  • Experience in the area of manufacturing operations
  • Ability to multi-task, prioritize and work independently

EDUCATION AND EXPERIENCE

  • B.S. degree in Engineering preferred, or equivalent experience.
  • Minimum of three (3) years as a Quality Engineer with medical device experience in manufacturing operations, process qualification, and quality engineering.
  • ASQ Certification a plus.

PHYSICAL DEMANDS

While performing the duties of this job the employee is frequently required to stand, sit, walk, talk, and hear. The employee is occasionally required to reach with hands and arms, stoop, kneel, or crouch.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

MISCELLANEOUS:

The duties listed above are intended only as illustrations of the various types of work that may be performed.  The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and the employee and is subject to change by the employer as the needs of the employer and requirements of the job change.