AbbVie

Senior Quality Engineer- Design Quality - Lifecycle Management

AbbVie • $100K — $130K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering, science, or a technical area
  • 6+ years relevant experience in the medical device industry, with 4+ years in Quality Assurance
  • Strong understanding of combination product and medical device regulations
  • Knowledge of 21 CFR 820, EU MDR 2017/745, ISO 13485, ISO 14971
  • Familiarity with Design Control under 21 CFR 820.30
  • Experience in product development and risk management
  • Strong oral and written communication skills

Responsibilities

  • Perform QA activities for Combination Product and Medical Device Design Transfer and Change Management
  • Serve as the primary quality lead for product launch design transfer activities
  • Support equipment qualifications and process validations
  • Own change plans for on-market design changes
  • Identify and track improvements within Design History File and Risk Management
  • Lead investigations for CAPAs, NCRs, and related quality issues
  • Drive continuous improvement initiatives across cross-functional teams

Benefits

  • Paid time off including vacation, holidays, and sick leave
  • Medical, dental, and vision insurance
  • 401(k) plan participation for eligible employees
  • Access to short-term incentive programs
Full 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 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
  • Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolutediscretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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