Leads & Managers Unique III

Location: Lake County (Hybrid)
Duration: 6 Months Contract

Visa Requirement: TN Visa is not acceptable. Visa must remain valid for the full 12-month duration.

We are seeking an experienced Design Quality Assurance professional to serve as the primary quality lead for project activities. The ideal candidate will be responsible for ensuring timely quality deliverables maintaining compliance standards and supporting successful product development initiatives within a regulated environment.

The candidate will work closely with cross-functional global teams to ensure design quality regulatory compliance and risk management activities are effectively executed throughout the product lifecycle.

• Serve as the primary quality lead for project activities to ensure on-time delivery high customer value and profitable outcomes.
• Drive quality and compliance aspects of projects related to combination products and medical devices.
• Ensure compliance with device drug and biologics regulations as applicable.
• Support and maintain adherence to company quality policies and procedures.
• Ensure proper Design History File (DHF) structure traceability and linkage between DHF elements.
• Manage design control documentation and design change control activities.
• Assess and justify the impact of product or design changes on safety efficacy and overall compliance.
• Support verification and validation activities requirements definition and specification development.
• Apply risk management methodologies and support risk assessments throughout the development process.
• Collaborate effectively within both individual and team-based work environments.

• Bachelors Degree in Engineering Life Sciences or another relevant technical discipline.
• Minimum 5 years of total industry experience.
• At least 3 years of experience in Device Design Quality Assurance.
• Experience working in pharmaceutical healthcare or other regulated industries.
• Strong understanding of:
  • DHF structure and traceability
  • Combination products and medical device regulations
  • Design controls and change management
  • Risk management methodologies
  • Product development lifecycle

• Systems Engineering experience
• Relational Database experience
• Strong analytical and problem-solving skills
• Ability to work independently and within global cross-functional teams
• Excellent communication and stakeholder management skills

• Combination of both individual contributor and collaborative team environment.
• Standard 40-hour work week.
• Preferred overlap with core business hours: 8:30 AM 4:30 PM CST.
• Limited overtime may be required under exceptional circumstances.

• Hybrid role for candidates located near Lake County IL.
• Expected in-office presence: Tuesday through Thursday.
• Remote flexibility available outside core hybrid days.