Quality Engineer in Boulder, CO at Tecomet

Date Posted: 4/21/2018

Job Snapshot

Job Description

Job Summary

This position will provide support to manufacturing processes assigned.  Manufacturing processes include machining and secondary processes. The person in this role will work independently requiring little guidance or supervision.  Guidance is typically at the level of overall goal definition and specific work objectives. It is the engineer’s responsibility to figure out the details and a solution that is in compliance with medical device regulations.   This role will also be responsible for participating in the development and maturation of the Quality Management System within manufacturing operations.

Essential Job Functions

  • Responsible for understanding the Tecomet Quality Management System (QMS) and medical device regulations.
  • Manage manufacturing validations which includes development of and authoring protocols, working with operations to execute activities, perform analysis and write reports.
  • Perform measurement system studies.
  • Develop statistically driven manufacturing inspection plans and methods for new products.
    • Create inspection plans from drawings and customer input, author procedures for inspection methods, and train manufacturing to those methods.
  • Project management skills and experience are required as you will lead projects/teams.
    • Lead small teams of engineers and others in performing validations, the development of inspection techniques and other projects as assigned.
  • Identification, evaluation and qualification of suppliers in conjunction with QA resources for new products and processes.
  • Manage and/or participate in CAPA process to resolve manufacturing related issues.
  • Participate in complaint investigations.
  • Assist in resolution of customer quality and/or discrepant material issues. Lead investigations and author rework Instructions, as necessary, for product.
  • Work with cross functional teams to identify and implement process improvements for existing products.
  • Lead cross functional teams in risk management activities according to medical device requirements.
  • Other duties as assigned by management.

Minimum Job Requirements

  • Bachelor’s Degree in mechanical engineering or other applicable technical field and  3-5+ years related experience, or equivalent combination of education and experience.
  • Preference will be given to candidates with working knowledge of ISO 13485 and 21 CFR 820
  • Proficient with Microsoft Office products
  • Excellent communication skills (verbal, written, presentation) with internal staff and customers 
  • Excellent organizational skills.
  • Excellent teamwork skills. 
  • Generally normal office hours but must be flexible with job hours to be successful in this position.

Physical Requirements

  1. Repetitive motions
    1. Movements frequently and regularly required using the wrists, hands, and/or fingers
  2. Visual abilities
    1. Average visual acuity necessary to prepare or inspect documents or products, or operate machinery, including personal computer
  3. Hearing
    1. Able to hear average or normal conversation
  4. Physical Strength
    1. Sedentary work; sitting most of the time
    2. Exerts up to 10 pounds of force occasionally

Note: This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. This job description does not restrict management’s right to assign or reassign duties and responsibilities to this job at any time.  Job descriptions are not intended and do not create employment contracts. 

** Final candidate must undergo and successfully complete a drug screen and background check **