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Staff Quality Engineer

Apply Now Job ID R-351016 Date posted 10/21/2019


Broken Bow, Nebraska
Franklin Lakes, New Jersey

Job Description Summary

This position is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry. The incumbent will cross-functionally support all quality activities and enforce regulatory requirements in support of product lines.

The position requires a self-motivated, self-directed individual able to handle multiple projects and tasks utilizing a high level of written and oral communication skills. The incumbent will become thoroughly knowledgeable with all aspects of large capital/new product development projects and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities.

The Staff Quality Engineer I reports to the Associate Director, Quality Management.

Job Description

  • Assist in developing methods to measure, validate and assure quality standards are achieved for applicable product lines.
  • Review process development/validation protocols for effectiveness and compliance to Corporate Guidelines.
  • Assist with Complaint Failure Investigations at the design center and manufacturing sites as necessary.
  • Serve as a multi-functional team leader for quality improvement teams assuring commitments and objectives are achieved with positive results.
  • Establish/maintain documentation for compliance and effectiveness.
  • Develop monitoring systems and action plans designed to maintain stability of the manufacturing process and to correct adverse situations.
  • Maintain knowledge of current technological advancements and industry standards for regulatory and compliance where deemed necessary and appropriate.
  • Use disciplined problem-solving processes and skills to diagnose and prevent/solve product design and manufacturing process issues.
  • Develop quality strategies to improve product quality as well as provide for more efficient processing of materials/products.
  • Assist and/or generate field issue investigation reports and assure timely close-out of all required actions associated with the field issue investigation process during the first year of a new product post-launch.

Minimum Job Requirements

  • At least10 years’ industry experience.
  • Proficient knowledge of Medical Device or pharmaceutical regulatory standards such as cGMP 21CFR820, ISO 13485, ISO 14971, ISO 10011, ISO 90011 and/or others relevant to Medical Devices.
  • Individual must understand expected results and establish efficient plans within assigned projects for self and/or team members to achieve them.
  • Individual must understand how process development and capability relates to product design.
  • Individual is expected to work in teams to obtain results, be self-motivated/directed, possess ability to organize and supervise activities with minimal supervision.
  • Individual is expected to independently interface with numerous functions, manufacturing plants, and supplies.  The individual is expected to prioritize and balance multiple priorities and commitments independently.
  • Individual is expected to perform multiple tasks and possess the ability to effectively manage conflict within those tasks.
  • Individual is expected to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.
  • Excellent skills in analytical thinking and problem solving.
  • Excellent written and oral communication skills.
  • Individual is expected to be able to read and understand component and assembly drawings as well as have a rudimentary knowledge of Geometric Dimensioning and Tolerancing.
  • Proficiency in Microsoft Office Suite and statistical programs – i.e., MiniTab, SAS, etc.

Primary Work Location

USA NE - Broken Bow

Additional Locations

USA NJ - Franklin Lakes

Work Shift

US BD 1st Shift 830am-5pm (United States of America)
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