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Manufacturing Line Quality Engineer

1 month ago

Scarborough, United States LanceSoft Full time
Job Title: Manufacturing Line Quality Engineer
Location: Westbrook, ME 04092
Duration: Current end date of assignment is 12/31/24, with a possibility of extension

hiring one 1st shift and 1 3rd shift Associate Line QE

Summarize the main purpose of the role:
Manufacturing Line Quality Engineers operate as an independent Quality resource partnered with Production to facilitate GMP, GDP and client quality standard compliance.
Responsible for assisting in the implementation and maintenance of an effective Quality System for the site.

Main Responsibilities:
  • Responsible for performing line clearance, shift change activities, set up verification and label verification.
  • Independently contribute to Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
  • Coach and reinforce quality attributes and requirements. May provide technical assistance.
  • Independently utilize quality management techniques to perform investigations and facilitate solutions.
  • Responsible for independently completing documentation in a timely manner and in accordance with business standards.
  • Responsible for maintaining the effectiveness of the Quality System.
  • Other tasks and duties as assigned.
  • Understand and comply with applicable EHS policies, procedures and guidelines.
  • Works under general supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment; identifies and quantifies technical risks and their consequences relative to the success of part of a project; recommends appropriate action; decisions or recommendations would typically achieve department / project objectives; drives functional performance to ensure that cross-functional standards and expectations are met; may assist in the training of personnel as directed by management; may mentor others.

Qualifications:
  • Bachelor's degree (± 16 years) in Related function
  • Master's degree (± 18 years) Preferred.

Experience/Background:
  • Minimum 2 years related experience.

Candidates / incumbents should possess the following:
  • Demonstrated technical competency and working technical knowledge and application of concepts, practices and procedures.
  • Ability or aptitude to work on problems of moderate scope
  • Ability to form and develop interpersonal, professional relationships.
  • Display socially and professionally appropriate behavior.
  • Ability to work independently and in groups.
  • Ability to work cross-functionally
  • Ability or aptitude to exercise judgment within defined procedures and practices to determine appropriate action
  • Demonstrated initiative and problem-solving skills
  • Critical-thinking skills
  • Ability and aptitude to use various types of databases and other computer software
  • Ability to prioritize; strong organizational and project management skills
  • Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.
  • Ability to quickly gain knowledge, understanding or skills and is willing to learn.