Quality Systems - Design Transfer Engineer
Collabera Inc.
Design, Quality Assurance
Chicago, IL, USA
USD 50-55 / hour
Posted on Aug 22, 2025
Quality Systems - Design Transfer Engineer
Contract: North Chicago, Illinois, US
Salary Range: 50.00 - 55.00 | Per Hour
Job Code: 364594
End Date: 2025-09-20
Days Left: 27 days, 9 hours left
Summary:
- 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.
- Responsible for 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, Aesthetics Devices, etc.
Responsibilities
- Primary driver for the quality and compliance aspects of Design transfer and on-market change management.
- Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside.
- Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.
- 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.
- Participate in the development of global Product Quality Assurance strategy to support device and combination products produced at plants as well as contract manufacturing and supplier facilities. Implements agreed strategy.
- Establish and maintain relationships and open communication with suppliers, contract manufacturers, 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 science, engineering, or other technical areas; or equivalent job experience required. Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.)
- 8+ years of relevant experience in the medical device industry; at least 5+ years in Quality Assurance experience required.
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 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 medical devices and/or combination products such as infusion pumps, PFS, Autoinjector, or Eyecare Products 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 environment.
- Excellent project management and interpersonal skills.
Pay Range:
- $50-55/Hr
Benefits:
- The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)
Job Requirement
- sub-cutaneous tubing
- Pre-filled Syringes
- Autoinjectors
- Eyecare Products
- Aesthetics Devices
- Infusion pumps
- MDR
- ISO 13485
- Design Control
- DFMEA
- combination products
- Medical Devices
- design change control
- DHF
- CAPAs
- CQA
- CQE
- SSBB
- Quality Assurance
- ISO 14971
- 21 CFR 4
- 21 CFR 820
- EUMDR
Reach Out to a Recruiter
- Recruiter
- Phone
- Sanjay Rawat
- sanjay.rawat@collabera.com