Job Details

ID #4508535
Estado Maine
Ciudad Westbrook
Full-time
Salario USD TBD TBD
Fuente Abbott
Showed 2020-08-04
Fecha 2020-08-05
Fecha tope 2020-10-04
Categoría Etcétera
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QA Supervisor

Maine, Westbrook 00000 Westbrook USA

Vacancy caducado!

Abbott Rapid Diagnostics is part of Abbott’s 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.The position of Supervisor, Quality Assurance is within our Infectious Disease Developed Markets business unit located at Westbrook, Maine. In this role you will be responsible for training and directing the work of direct reports in their designated responsibilities and assisting in and/or driving the maintenance of certain areas of the quality system and promoting quality awareness throughout the organization.RESPONSIBILITIES: Corrective and Preventative Action (CAPA) process : assure compliance to applicable standards. Write and maintain the program's SOPs, provide training, develop and generate relevant metrics and trending. Quality Incident process: assure compliance to applicable standards. Write and maintain the program's SOPs, provide training, develop and generate relevant metrics and trending. Internal and External Audit: Responsible for lead audit support activities. Qualifications and Validations: Review qualifications, validations, and other studies for technical content, statistical rationale, risk and clarity. Act as the Quality representative for qualification and validation approvals for production equipment. Product Stability Program: assure compliance to applicable standards for launched products. Supplier Assessment Program: Primary Quality Assurance contact for day to day maintenance of supplier assessment documentation and processes. May participate in Supplier auditing. Product Quality Assurance: Responsible for product release. Develop test and inspection plans; assure product test requirements align with product performance and labeling claims. 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, and determine areas where SPC may be used as a process control and assist in its implementation where appropriate. Document Control : Management of the document control process and review of document changes from a QA perspective. Assure compliance to applicable standards. Write and maintain the program's SOPs, provide training, develop and generate relevant metrics and trending. Calibration Program : assure compliance to applicable standards. Write and maintain the program's SOPs, provide training, develop and generate relevant metrics and trending.Customer Complaint investigationo Management of Electronic case updates and metric generation as needed.o Functional testing to support case investigation (assay products and instruments).o Instrument decontamination program to support investigation activities by internal and external resources, and to support refurbishment activities.o assure compliance to applicable standards. Write and maintain the program's SOPs, provide training, develop and generate relevant metrics and trending.o Alert management to any trends noted from metrics and trending of products in the field.o May lead technical investigations into product abnormalities.Supervisory Responsibilities· Directly supervises employees in the Quality Assurance department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.BASIC QUALIFICATIONS | EDUCATION:· Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science or related technical field or equivalent experience and education.· 3+ years’ experience in a medical device company in a quality or regulatory function· Ability to travel 10% of the timePREFERRED QUALIFICATIONS:· Prior lead or supervisory experience.· Certified Quality Assurance (CQA)COMPETENCIES:· Proficiency with Word, Excel and Internet software. Experience with Databases, Agile, and Salesforce are highly desirable.· Working knowledge of FDA cGMPs/QSR, USDA 9CFR, CLIA, IVDD and ISO Quality system requirements· Demonstrated understanding of lab practicesBASIC QUALIFICATIONS | EDUCATION:· Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science or related technical field or equivalent experience and education.· 3+ years’ experience in a medical device company in a quality or regulatory function· Ability to travel 10% of the timePREFERRED QUALIFICATIONS:· Prior lead or supervisory experience.· Certified Quality Assurance (CQA)COMPETENCIES:· Proficiency with Word, Excel and Internet software. Experience with Databases, Agile, and Salesforce are highly desirable.· Working knowledge of FDA cGMPs/QSR, USDA 9CFR, CLIA, IVDD and ISO Quality system requirements· Demonstrated understanding of lab practicesAn Equal Opportunity EmployerAbbot welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.To request accommodation, please call 224-667-4913 or email [email protected]

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