Senior Quality Engineer- Design Quality – Lifecycle Management

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Sr. QE for Design Quality – Lifecycle Management

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, Eyecare Products, Aesthetic Devices, etc. 

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 System
  • Maintain DHF documentation
  • Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
  • Perform 3rd party supplier management activities such as review 3rd party design control activities
  • Support the creation of regulatory submission documentation
• Serves 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 validations
• Own 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 closure
• Identify 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 documents
• Apply 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 department
• Support interactions with regulatory authorities (e.g., Notified Body audits)
• Write and revise procedures, forms, and other documents, as needed
• Work with the cross-functional team to drive change and continuous improvement

Qualifications

• Bachelor’s degree in engineering, science or other technical areas
• 6+ years of relevant experience in the medical device industry;  4+ years of Quality Assurance experience required.
• 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 14971
• Working knowledge of Design Control per 21 CFR 820.30
• Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
• Product 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 cle