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Quality Assurance Manager

1 month ago

Westbrook, Maine, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Job Title: Quality Engineer Manager

We are seeking a highly skilled Quality Engineer Manager to join our team at Abbott Rapid Diagnostics Scarborough, Inc. in Westbrook, Maine. As a Quality Engineer Manager, you will be responsible for managing, training, and supporting the work of the Quality Engineer team in their designated responsibilities.

Key Responsibilities:
  • Manage and support the Quality Engineer team in their designated responsibilities
  • Provide audit readiness support and data generation for periodic management or Change Review Board meetings
  • Participate in and oversee the management of designated quality engineer reports, reviewing qualifications, validations, and other studies for technical content, statistical and sampling rationale, unintended impact, and clarity
  • Act as the quality representative for qualification and validation approvals for all validated equipment
  • Review and assess from a technical perspective the content of all manufacturing, process, procedure, and material changes
  • Assist in process data collection and analysis, provide training in the use of statistical techniques as needed
  • Participate in the Material Review Board (MRB)
  • Act as the quality representative in the review and disposition of non-conformances, assuring appropriate decisions, testing, data, and records are completed
  • Act as a technical resource to assure customer-centric resolution to non-conformances
  • Facilitate Validation Review Board
  • Act as the quality representative for review and approval of reports and documents associated with change management and may also act as project manager for change management activities
  • Supports development to risk assessments around the changes
  • Act as the quality representative in the review and approval of Risk Management Files and providing input into the Risk Management Process
  • Develop and support the quality assurance training programs as needed
  • Support the development of test and inspection plans
Requirements:
  • Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science, or other technical field or the equivalent combination of education and experience
  • 10+ years' experience in quality and/or regulatory roles in regulated industry (i.e., Medical Diagnostics, Medical Device, Pharmaceutical, etc.)
  • Working knowledge of database software, Internet software, Inventory software, Spreadsheet software, Word Processing software, and statistical software
  • Working knowledge of FDA, cGMPs/QSR, and ISO quality system requirements
  • Strong technical writing skills and effective communication skills
Preferred Qualifications:
  • Experience with Lean / Six Sigma
  • Experience working in a broader enterprise/cross-division model
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage, and/or engage others to accomplish projects
  • Multitasks, prioritizes, and meets deadlines in a timely manner
  • Strong organizational and follow-up skills, as well as attention to detail
About the Opportunity

This position works out of our Westbrook, Maine location in Abbott Rapid Diagnostics Scarborough, Inc. Abbott Rapid Diagnostics is part of Abbott's Rapid and Molecular Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

What We Offer

At Abbott Laboratories, we offer a competitive salary range of $95,000.00 – $190,000.00, depending on the location. We also offer a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced Quality Engineer Manager looking for a new challenge, please submit your application.