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Senior Engineer, Quality

1 month ago

Southington, United States ICU Medical Full time
Description

Job Title: Sr. Quality Engineer (Quality Operations)

Position is 100% onsite in Southington CT

FLSA Status: Exempt

Position Summary

The Senior Quality Engineer (Quality Operation) provides hands-on technical quality engineering support and direction in quality assurance and quality control aspects of the operation to facilitate an environment of compliance and meeting business objectives.

The position requires good knowledge on the disciplines within a medical device QMS and knowledge and understanding of manufacturing and quality control processes. The incumbent will focus on verification and validations of products and processes and to the proper resolution of nonconformances at any point during the validation process. This position will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulation and standards.

The person in this role must have good communication and leadership skill and the ability to plan, multi-task and manage time effectively to maintain ensure activities associated to the role are properly accomplished to avoid regulatory risk.

Essential Duties & Responsibilities

  • Partner with Engineering, Maintenance, Production, Quality Operation and other functions to drive prompt resolution of quality problems for product and processes and to drive the highest quality results.
  • Implement quality engineering tools in the operation to drive methodical and process-based approaches to product and process improvements.
  • Develop sampling plans by applying attribute, variable, and sequential sampling methods.
  • Develop local procedures, Test Methods, and standards.
  • Manages testing outlined in protocols and test methods.
  • Manages/develops validation studies on equipment & processes.
  • Initiate, manage and support of ship, product holds, potential product escapes associated to nonconformances.
  • Have the ability to methodically process and investigate in a high paced, efficient and accurate manner.
  • Proactively escalate significant quality issues observed while running the processes under responsibility and propose solutions.
  • Be proficient in and make continuous strides towards optimization of inspection methods and sampling.
  • Coach and mentor others in quality topics and activities.
  • Working effectively in a team environment with shifting priorities and time sensitive requirements.
  • Performs other functions as necessary or as assigned.
  • Work on special projects as they arise Ability to train/transfer knowledge to others
  • Proficiency in quality toolbox including six sigma methodology, lean principles, and advanced statistics and other proven tools.
  • Use of measurement and test equipment
  • Must be a creative problem solver with the ability to troubleshoot a variety of issues
  • Good written and verbal communications skills
  • Knowledge of plastic processing, automated and manual assembly of disposable Medical Device.
  • Must have good mechanical aptitude
  • Demonstrate ability to safely and competently handle returned contaminated medical devices.


Knowledge, Skills & Qualifications; Proficient in Microsoft Office (Excel, Word, Database) and statistical analysis programs

Education and Experience: •Bachelor's Degree in an Engineering discipline (Biomedical, Mechanical, Industrial, or Manufacturing Engineering). •CQE Certification desirable. •Experience working in a team environment successfully bringing medical device products through an FDA regulatory pathway and compliance with internal Quality Management System (QMS). •Experience writing documents in regulated industries.

Minimum Qualifications •Must be 18 years of age

Travel Requirements: •Typically requires travel less than 15% of the time

Physical Requirements and Work Environment: •Work is performed in a safe environment. While performing the duties of this job, the employee is regularly required to work inside a clean room/controlled area environment. Use of computer to enter and review data; use telephone and web conferring to converse.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.