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Assoc Engineer - Quality

Helical Products Co.

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Mansfield, MA
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Job Description

As posted by the hiring company

Job Overview:

ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:

  • Create, implement and revise Quality inspection plans, procedures and documents to maintain compliance with ISO/FDA regulatory requirements and QMS improvement
  • Continuous improvement activities as they apply to Quality, such as, but not limited to, improved inspection methods, etc.
  • Perform investigations on quality related issues, including, but not limited to, CAPA, Complaints, Root Cause Analysis, and maintenance of all documentation.
  • Assist in the Non-Conforming Material (NCR) process.
  • Interface with customer and suppliers concerning quality matters, as required.
  • Provide necessary technical support to other departments such as, sustaining and manufacturing.
  • Work with all departments in implementing and complying with Quality Systems and cGMP requirements.
  • Assist in training inspection and production employees as required.
  • Other responsibilities as required.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements that follow are representative of the knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Once initially qualified, the employee’s continuing competency is appraised during the introductory period.  Long-term competency is evaluated by the supervisor, using work quality and continuous training as deemed necessary. 

LANGUAGE SKILLS:

Ability to read, write and speak fluently in English.  Ability to read and understand common trade and technical publications, blueprints, technical reports and specifications.  Ability to write reports and general business correspondence and communicate with all levels of personnel, both internal and external to the organization.

MATHEMATICAL SKILLS:

Ability to add, subtract, multiply and divide using various units of measure (fractions, decimals, etc.)  Ability to recognize amounts and compute ratios and percentages. Knowledge of basic statistics and statistical programs such as, but not limited to, MiniTab is a plus.

REASONING ABILITY:

Ability to define problems, collect data, establish facts and draw valid conclusions.  Ability to interpret a variety of technical instructions and documents.  Ability to detect and identify typical defects found in materials.  Ability to read and use various inspection equipment applications and precision tools and understand and apply basic quality inspection technologies/measurement practices.  Knowledge of Micro-Vu equipment and programming is a plus.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is frequently required to sit, stand, walk, reach handle and feel.  Ability to move/lift objects weighing between 30- 50 pounds may be occasionally required.  Specific vision abilities required by this job may include close vision, distance vision, color vision, peripheral vision, depth perception and ability to focus.

WORK ENVIRONMENT

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.  Use of vision correction is acceptable as required: however, any vision correction apparatus must meet all safety guidelines for the area of use.

While performing the duties of this job, the employee is constantly exposed to a typical office environment.  The noise level in this office work environment is usually quiet.  The employee may frequently be exposed to a laboratory or testing environment.  The employee may frequently be exposed to a manufacturing (non-temperature-controlled) and warehouse environment; the noise level in this environment is usually loud and there is dust and odors.    

WORKING CONDITIONS

Occasional travel may be required. 

EDUCATION and/or EXPERIENCE:

Required:

  • Associate degree in quality or engineering or equivalent, or four (4) years of working experience in quality engineering.
  • Zero (0) to three (3) years’ experience in quality engineering, preferably in the medical device industry.

Desired:

  • Experience in a medical device manufacturing environment
  • Knowledge and experience with ISO 13485:2016 and FDA QSR 21 CFR:820
  • ASQ certification such as, but not limited to, Certified Quality Engineer (CQE)
  • Knowledge of statistical programs such as Minitab
  • Working knowledge of Micro Vu vision system/programming

SKILLS/COMPETENCIES

  • Read/write/speak and understand English
  • Working knowledge of Microsoft Office applications
  • Excellent interpersonal and communication skills to work with associates, suppliers, and customers when required
  • Ability to understand and interpret basic manufacturing documentation, i.e.: Bills of Materials (BOMs), routers, etc.
  • Ability to multi-task in a fast-paced environment and manage multiple/shifting priorities
  • Problem solving capability
  • Ability to work under minimal direction and self-motivated