Senior Quality Engineer- Design Quality Lifecycle Management

BioSpace; North Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

PTO & Holidays

Medical/Dental/Vision

401(k)

STI eligibility

Job summary

AbbVie is seeking a Sr. QE for Design Quality Lifecycle Management to ensure smooth transfer from development to manufacturing of medical devices and combination products.

You will lead design transfer activities, support IQ/OQ/PQ and process validations, drive CAPA and change control, and collaborate with regulatory bodies to maintain compliance worldwide.

This role requires strong collaboration with cross-functional teams and a proactive approach to quality improvements.

Qualifications

• Bachelor's degree in Biology, Chemistry or Engineering.
• 6+ years in Manufacturing, Quality, or Engineering.
• Strong verbal and written communication.
• Strong problem solving and analytical skills.
• Good interpersonal, negotiation and collaboration abilities.
• Knowledge of quality/compliance regs affecting API, Bulk Drug or finished goods manufacturing.

Responsibilities

• Perform QA activities for Design Transfer and Change Management.
• Ensure compliance with policies; maintain DHF docs.
• Lead design transfer activities for product launches.
• Support equipment qualifications (IQ/OQ/PQ) and process validations.
• Lead CAPA investigations and change control.
• Collaborate with regulatory authorities and audits.

Skills

Verbal and written communication

Problem solving

Analytical skills

Interpersonal skills

Negotiation skills

Quality/compliance knowledge

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job 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.

Company Description

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, preferably in Biology, Chemistry or Engineering
• 6+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Additional Information

• 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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html