Enter a job title or keyword

Manager, Design Quality – Lifecycle Management

TekWissen LLC

Job Location:

North Chicago, IL - USA

Monthly Salary: Not provided by the employer

Posted: 19 May 2026 (30+ days ago)

Application Deadline: 16 August 2026

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. This Client is mission is to discover and deliver innovative medicines and solutions that address complex health issues and enhance people s lives.

Position: Manager Design Quality Lifecycle Management
Location: North Chicago IL 60085
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Hybrid

Job Description:

Manager 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:

Primary driver for the quality and compliance aspects of product transfer and on-market change management.
Serves as the primary quality lead for design transfer activities to enable product launch including transfers both within and outside of AbbVie.
Lead/support process validation activities (IQ/OQ/PQ/PPQ) including TMV.
Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
Lead/support lifecycle design change projects following Design Control and Change Control principles
Own change plans to manage on-market design changes collaborate with cross-functional team for impact assessments define and execute action plans and monitor to ensure timely closure.
Ensure design control documentation (Traceability/Linkages) & design change control requirements are met.
Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure.
Assist 3rd party suppliers during change management process including change management strategies
Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME.
Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
Makes recommendations for key decisions on product quality compliance and regulatory conformance issues
Establishes and maintains relationships and open communication with suppliers contract manufacturers AbbVie plants affiliates and other functional groups to maintain roles and responsibilities identify potential projects and issues obtain an in-depth understanding of the quality compliance and resource needs at each site and provide guidance on quality concerns.
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
Conduct lead or participate in investigations and review boards for Change Plans CAPAs NCRs Observations etc.

Qualifications:

Bachelor s degree in engineering science or other technical areas; Advanced degree preferred; ASQ certification preferred (CQA CQE SSBB etc.)
8 years of relevant experience in the medical device or combination product industry; 5 years of Quality Assurance experience required.
Working knowledge of ISO 13485 ISOCFR 4 21 CFR 820 EU Regulation 93/42/EEC (MDD) & 2017/745 (MDR)
Working knowledge of international standards and regulations applicable to medical devices and combination products
Experience with infusion pumps PFS Autoinjector or On Body Injector preferred.
Ability to apply practical and technical problem solving to quality system and product improvements
Excellent interpersonal skills including ability to work effectively cross-culturally and cross-functionally.
Proven ability to effectively lead cross-functional teams and to influence where direct reporting line relationships do not exist.
Capable of developing matrix relationships with key colleagues in other functional areas and divisions; Recognizes other colleagues areas of expertise and utilizes them effectively to achieve team objectives
Champions high quality deliverables innovation and appropriate risk-based decision making; Ability to understand the sensitivities within the AbbVie s environment.
Excellent project management and interpersonal skills
Adaptable to changes in work environment
Ability to work in a fast-paced environment
Able to travel up to 10% of the time.

What are the top 3-5 skills experience or education required for this position:

Design Control Principles
Change Control Principles
Working knowledge of Medical Devices and Combination Products (MDCP) such as Infusion Pumps On Body Injectors PFS
FDA/EU regulations on MDCP
Applicable standards

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Apply Now