Quality Engineer

  • Job ref:


  • Location:

    San Marcos, United States

  • Sector:

    Quality Engineers

  • Contact:

    Bill Hurynowicz

  • Published:

    4 months ago

  • Consultant:


Key Responsibilities:

  • Analyze, identify, develop and implement manufacturing, production, and other process improvements which will improve capability, and/or performance.  
  • Function as a lead team member for process improvements, ensuring all activities occur to conclude projects as per plans while coordinating activities across cross-functional groups.
  • Develop and lead training initiatives of department staff as directed.
  • Identify, and resolve manufacturing/ production line work problems in a timely manner.
  • Meet with appropriate teams and/or individuals to offer recommendations and share results.
  • Act as liaison with managers, staff, and customers to coordinate procedures that address any process or product deficiency.  
  • Enable positive channels of communication to ensure highest level of customer satisfaction.
  • Represent Quality and Manufacturing Engineering on new product development teams and smoothly transition new designs into production.
  • Develop, prepare and implement Quality Program plans for new and existing customers specific to validation and qualification activities.
  • Write, review, and approve validations (installation qualification IQ/operational qualification, OQ/performance qualification PQ protocols, Standard Operating Procedures (SOP), technical reports and final reports) for new products, processes, and equipment; ensure systems, utilities, and processes comply with the Food and Drug Administration (FDA) and industry standards.
  • Participate in new design product/design review in order to ensure quality requirements are identified and captured in appropriate documentation.
  • Actively participate in internal, customer, and third-party audits.
  • Other duties as assigned.

Knowledge, Skills and Abilities Required:

  • Manage time wisely and effectively prioritize multiple competing tasks.
  • Ability to identify and solve problems, develop innovate solutions, act decisively and apply good judgement.
  • Readily able to offer opinions and take action when the position may be unpopular.
  • Skilled at handling situations diplomatically.
  • Proven team player who has demonstrated capabilities in the following areas: excellent communication, interpersonal skills, well developed problem-solving skills; solid organizational skills and the demonstrated ability to be self-directed and effectively relate to all levels of the organization.
  • Strong computer skills a must, to include Word, Excel, PowerPoint; experience with Access Database is a plus.


Education and Experience:

Bachelor of Science degree in Mechanical Engineering or similar.  Minimum 5 years’ experience as a Quality Engineer in a manufacturing environment.  Diagnostics, pharmaceutical or Biological products manufacturing environment is preferred.  ISO13485 and ISO09001 Internal Auditing Training. Six Sigma and Lean Manufacturing experience a plus.