About this role
Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include medical devices and combination products, such as infusion pumps, enteral and sub-cutaneous tubing, Pre-filled Syringes, Autoinjectors, On Body Injector (OBI), Eyecare Products, Aesthetic Devices, etc. This role will provide quality oversight for OBI product transfer to Heredia site at Costa Rica.
Responsibilities:
Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management:Ensure compliance with company policies and procedures.Perform design control and risk management activities according to AbbVie's Quality SystemMaintain DHF documentationPartner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are metPerform 3rd party supplier management activities such as review 3rd party design control activitiesSupport the creation of regulatory submission documentationServes as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie.Support equipment qualifications (IQ/OQ/PQ) and process validationsOwn change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor them to ensure timely closureIdentify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documentsApply knowledge of global regulations, guidance's, and Corporate and Function standards.Lead/assist in the preparation of and support regulatory agency and internal audits.Conduct, lead, or participate in investigations and review boards for CAPAs, NCRs, Observations, etc.Participate in departmental Change Control activities, utilizing Design Control knowledge to perform design change impact assessments.Review and approve changes relevant to the departmentSupport interactions with regulatory authorities (e.g., Notified Body audits)Write and revise procedures, forms, and other documents, as neededWork with the cross-functional team to drive change and continuous improvement Bachelor’s degree in engineering, science or other technical areas6+ years of relevant experience in the medical device industry; 4+ years of Quality Assurance experience required.English proficiency: B2+Strong understanding of regulations and standards affecting combination products and medical devices.Working knowledge of 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971Working knowledge of Design Control per 21 CFR 820.30Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skillsProduct development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management.Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issuesInterpersonal, team, leadership, and negotiation skills to handle conflicting prioritiesStrong oral and written communication skills, excellent interpersonal and cross-cultural skills required. Capable of clearly presenting and justifying quality requirements to managementAccreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE). AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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