Senior Quality Engineer- Design Quality – Lifecycle Management

AbbVie•North Chicago, IL

About The Position

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.

Requirements

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 clearly communicate the quality position, and the actions necessary to resolve issues
Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required.
Capable of clearly presenting and justifying quality requirements to management

Nice To Haves

Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).

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