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Staff Quality Engineer

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

Locations

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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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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