Quality Assurance Engineer for Manufacturing Operations

2 weeks ago


Scarborough, Maine, United States LanceSoft Full time
Job Title: Quality Assurance Engineer for Manufacturing Operations
Location: Westbrook, ME
Duration: Current assignment with potential for extension

Role Overview:
The Quality Assurance Engineer for Manufacturing Operations serves as a vital Quality resource collaborating with Production to ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and client quality standards. This role is crucial in supporting the establishment and upkeep of an effective Quality Management System for the facility.

Key Responsibilities:
  • Conduct line clearance, manage shift transitions, and verify setups and labels.
  • Actively contribute to Quality Management System processes, including training, corrective and preventive actions (CAPA), equipment upkeep, product and process planning, quality audits, and validation.
  • Mentor and reinforce quality standards and expectations, providing technical support as needed.
  • Utilize quality management methodologies to conduct investigations and facilitate effective solutions.
  • Ensure timely and accurate completion of documentation in line with business standards.
  • Maintain the effectiveness of the Quality Management System.
  • Undertake additional tasks and responsibilities as assigned.
  • Adhere to relevant Environmental, Health, and Safety (EHS) policies, procedures, and guidelines.
  • Operate under the general guidance of more experienced personnel, who review outcomes for overall accuracy and sound judgment; identify and assess technical risks and their implications on project success; recommend appropriate actions; contribute to achieving departmental and project objectives; enhance functional performance to meet cross-functional standards and expectations; assist in training personnel as directed by management; and provide mentorship to others.
Qualifications:
  • Bachelor's degree in a related field.
  • Master's degree is preferred.
Experience and Background:
  • Minimum of 2 years of relevant experience.
Desired Skills:
  • Proven technical proficiency and practical knowledge of concepts, practices, and procedures.
  • Ability to address moderately complex problems.
  • Strong interpersonal and professional relationship-building skills.
  • Professional and socially appropriate conduct.
  • Capability to work autonomously as well as collaboratively.
  • Proficiency in cross-functional teamwork.
  • Judicious decision-making within established procedures and practices.
  • Demonstrated initiative and effective problem-solving abilities.
  • Strong critical-thinking skills.
  • Proficient in utilizing various databases and software applications.
  • Excellent organizational and project management capabilities.
  • Ability to devise solutions and contingency plans through thorough evaluation of alternatives.
  • Quick learner with a willingness to acquire new knowledge and skills.


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