Best Practices, Biotech and Pharmaceutical, Change Control, Change Management, Code of Federal Regulations, Continuous Improvement, Contract Manufacturing, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, FDA (Food and Drug Administration), Healthcare Quality, ISO (International Organization for Standardization), Infusion Pumps, Leadership, Manufacturing, Manufacturing Requirements, Medical Equipment, Medical Office Administration, Policy Development, Procedure Development, Process Improvement, Process Validation, Product Design, Product Lifecycle Management, Product Support, Product/Service Launch, Project Lifecycle, Project/Program Management, Quality Assurance, Quality Assurance Methodology, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Management, Supply Chain, Traceability, Validation Testing
Hi,
My name is Karthik Mutyala and I'm a Recruitment Manager with Stark Pharma, specializing in pharmaceutical, biotechnology, and medical device roles. I came across your profile and wanted to see if you are open to new opportunities.
If interested, please send me your updated resume along with the best number and time to reach you.
Job Title: Manager, Design Quality Lifecycle Management
Location: Lake County, IL (Hybrid)
Duration: 12+ Month Contract
Job Summary
We are seeking an experienced Manager, Design Quality Lifecycle Management to support quality assurance and compliance activities for medical devices and combination products throughout product lifecycle management. This role will serve as the Quality representative on cross-functional teams, ensuring successful product transfers, design changes, validation activities, and ongoing compliance with global regulatory requirements.
The ideal candidate will have deep expertise in Design Controls, Change Management, Risk Management, and lifecycle quality support for medical devices and combination products such as infusion pumps, pre-filled syringes, autoinjectors, and on-body injectors.
Key Responsibilities
- Lead quality and compliance activities related to product transfer, commercialization, and on-market lifecycle management
- Serve as the primary Quality lead for design transfer activities supporting internal and external manufacturing sites
- Lead and support validation activities including IQ/OQ/PQ/PPQ and Test Method Validation (TMV)
- Drive lifecycle design change projects in accordance with Design Control and Change Control requirements
- Own change management plans, impact assessments, execution strategies, and closure activities for on-market product changes
- Ensure Design History File (DHF), traceability, and risk management documentation remain compliant and inspection-ready
- Identify and drive remediation of gaps within design control, risk management, and quality system processes
- Support supplier and contract manufacturing quality activities during design and process changes
- Participate in regulatory inspections, audits, CAPA investigations, NCR reviews, and quality review boards as a Subject Matter Expert (SME)
- Collaborate cross-functionally with Engineering, Manufacturing, Regulatory, Supply Chain, and external partners to ensure product quality and compliance
- Contribute to continuous improvement initiatives and development of quality procedures, policies, and best practices
Required Qualifications
- Bachelor's degree in Engineering, Science, or related technical discipline
- 8+ years of experience within Medical Device or Combination Product industries
- 5+ years of Quality Assurance experience supporting regulated products
Strong expertise in:
- Design Controls
- Change Control
- Risk Management
- Product Lifecycle Management
- Validation activities (IQ/OQ/PQ/PPQ)
Experience supporting medical devices and combination products such as:
- Infusion Pumps
- Pre-filled Syringes (PFS)
- Autoinjectors
- On-Body Injectors
Working knowledge of:
- FDA 21 CFR Part 820
- FDA 21 CFR Part 4
- ISO 13485
- ISO 14971
- EU MDR (2017/745) and MDD requirements
- Strong project management, communication, and cross-functional leadership skills
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Stark Pharma Solutions Inc