Step into a high-impact leadership role where you will safeguard the integrity of life-changing medical technologies. As the Manager of Design Quality for Lifecycle Management, you will be the primary driver for quality and compliance, overseeing product transfers and on-market change management for a diverse portfolio including infusion pumps, autoinjectors, and aesthetic devices. This is a chance to lead cross-functional teams through complex design control and validation activities, ensuring that every product reaching the patient meets the highest global regulatory standards.
The work is performed at a world-class, state-of-the-art innovation hub in North Chicago that houses cutting-edge R&D labs and advanced manufacturing support, fostering a collaborative environment dedicated to complex therapeutic solutions. You will play a pivotal role in bridging the gap between development and manufacturing,
location: North Chicago, Illinois
job type: Contract
salary: $95.00 - 104.96 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Lead Design Transfer & Change Management: Serve as the primary Quality lead for design transfer activities and on-market design changes, ensuring seamless transitions from development to manufacturing both internally and with external partners.
- Drive Validation Excellence: Lead and support comprehensive process validation activities, including IQ/OQ/PQ/PPQ and Test Method Validation (TMV), to ensure robust manufacturing processes.
- Oversee Design Controls: Own and manage Change Plans, ensuring all design control documentation, traceability, and linkages remain compliant throughout the product lifecycle.
- Manage Risk & Compliance: Identify and remediate gaps within the Design History File (DHF) and Risk Management files, tracking all improvements and mitigations to closure.
- Cross-Functional Leadership: Mentor product team members through the design control process and lead solution development for complex quality system improvements.
- Audit & Inspection Support: Act as the Subject Matter Expert (SME) for Quality Assurance during internal audits and external regulatory inspections (FDA/EMA).
qualifications:
Required Skills
- Education: Bachelor's degree in Engineering, Science, or a related technical field.
- Experience: Minimum of 8 years in the medical device or combination product industry, with at least 5 years specifically in Quality Assurance.
- Regulatory Mastery: Deep working knowledge of 21 CFR 820, 21 CFR 4, ISO 13485, ISO 14971, and EU MDR (2017/745).
- Technical Proficiency: Solid understanding of Design Control principles, Change Control, and Risk Management.
- Validation: Hands-on experience with process validation (IQ/OQ/PQ) and TMV.
- Advanced Education: Master's degree in a technical or business field.
- Certifications: ASQ certifications such as CQA, CQE, or Six Sigma Black Belt (SSBB).
- Product Expertise: Direct experience with Infusion Pumps, Pre-filled Syringes (PFS), Autoinjectors, or On-Body Injectors.
- Supplier Quality: Experience assisting 3rd party suppliers with change management strategies.
skills: OQ, Corrective and Preventive Actions (CAPA), Deviation Investigation, Process Validation, Change Control Management, Quality Assurance (QA)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
