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Quality Engineer

2 months ago

Anoka, United States Dynamic Group Inc Full time
Job DescriptionJob DescriptionDescription:

POSITION DETAILS

JOB PURPOSE Provide quality engineering support to the medical molding manufacturing and product realization processes to ensure quality and productivity expectations are met.

DUTIES AND RESPONSIBILITIES • Act as a quality interface for engineering and production regarding customer validation and complaints.

  • Oversee Supplier Change Requests.
  • Support validation activity of processes, equipment, and metrology.
  • Write protocol/validation plans.
  • Analyze data.
  • Write final validation reports.
  • Oversee Software Validations.
  • Quality engineering support for manufacturing and project management.
  • Print/inspection interpretations.
  • Understand customer product requirements.
  • Best Measurement Practices.
  • Good Documentation Practices.
  • Lead, manage and support Corrective Actions.
  • Use failure analysis, development of corrective and preventative actions and trend analysis to find waste.
  • Take on internal process improvement opportunities (Rocks).
  • Travel as required to support and meet the needs of our customers and suppliers.
  • Adhere to ISO13845 standards for all documents and procedures.
  • Continuously looking for ways to improve the customer experience.

WORKING CONDITIONS The employee is subject to normal manufacturing and office environments.

DIRECT REPORTS N/A


Requirements:

QUALIFICATIONS

MINIMUM EXPERIENCE REQUIREMENTS • Minimum 3 years of experience in engineering in a machining or manufacturing setting.

  • Knowledge of inspection equipment use including CMM, VMM, Calipers, Micrometers, Gages, Drop Indicators and other quality equipment.
  • Understand and apply statistics, data analysis and trending and reporting of results (Control Chart, Sampling Plans, Gage R&R and DOE).

PREFERRED EXPERIENCE REQUIREMENTS • 3 years quality engineering experience in a plastic injection molding manufacturing environment.

  • Medical device industry experience including ISO 13485 & FDA CFR Part 820.
  • CMM/VCMM Programming.
  • Minitab experience helpful.


MINIMUM EDUCATION REQUIREMENTS Bachelor's Degree in Quality, Mechanical, Industrial, or in another Engineering Science.

PREFERRED EDUCATION REQUIREMENTS

REQUIRED SKILLS • Strong problem solving skills.

  • Effective understanding of process capability principals.
  • Effective understanding of GD&T.
  • Effective use of Microsoft Office (Outlook, Word, Excel).
  • Effective ability to generate and train others on process and technical documentation.
  • Proficient use of ERP software.
  • Ability to work within a cross functional team.
  • Ability to work independently, multi-task, and prioritize.
  • Effective communication skills.
  • Attention to detail.

PHYSICAL REQUIREMENTS The employee is required to sit, move about, reach, handle, and feel.

VISUAL ACUITY As required, with or without accommodation, for reading written documents, design prints and computer screens.

HEARING ABILITY As required, with or without accommodation, for hearing the telephone and communicating with customers, co-workers and visitors.