We are recruiting for a QUALITY ENGINEER to join our team within our Infectious Disease Developed Markets business unit located in Scarborough, ME. In this role you will provide support for contract manufacturing, product quality assurance, change management, process improvements, and quality system programs.
Primary Responsibilities
Qualifications and Validations:
Review 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
Nonconformance Investigation:
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
Supplier Management Program:
Act as the Quality representative for day to day maintenance of supplier management documentation and processes
Support a contract manufactured product line
Change Control:
Act as the Quality representative for review, approval and implementation of change control records
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
Required Qualifications
Bachelor's Degree in Engineering, Chemistry, Biotechnology, Life Science or other technical field
2-5 years of quality experience in a regulated environment (i.e. medical device, aerospace, defense, pharmaceutical, etc.)
Previous technical writing experience and working on CAPA investigations
Proficient in MS Office (Word, Excel, Outlook)
Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
Preferred Qualifications
Advanced level degree in Biology, Chemistry, Life Sciences, or other related technical field
Previous medical device experience
Technical writing skills
Working knowledge of FDA, cGMPs/QSR and ISO quality system requirements
Alere, Inc.(Now Abbott) is an equal employment/affirmative action employer of Minorities/Females/Protected Veterans/Disabled. If you need accommodation for any part of the employment process because of a disability please send an email to jobs@alere.com to let us know the nature of your request
