Site CQV Lead — Medical Device Start-Up (Contract)

CAPU Search; Wisconsin; On-site; USD 96,000 - 165,000; Part time

Job summary

CAPU Search is supporting a medical device manufacturer with a new Wisconsin site build, seeking a Site Qualification & Validation Lead to own the CQV program end-to-end. You’ll plan, supervise contractors, and ensure the facility is qualified, audit-ready, and on schedule.

The role emphasizes ownership over commissioning and qualification strategies, PQ through to transfer, and collaboration with quality to achieve ISO 13485 and 21 CFR 820 compliance for a regulated manufacturing environment.

Qualifications

• Experience leading a new site start-up or full site transfer in a regulated manufacturing environment.
• Strong CQV background: IQ/OQ/PQ, PPQ, cleanroom and utilities qualification.
• Medical device background with ISO 13485 and 21 CFR 820.
• Experience managing contractors and capital project budgets; not hands-on protocol execution.

Responsibilities

• Own commissioning, qualification and validation strategy for the new site.
• Lead equipment and facility qualification through to PQ: cleanrooms, utilities, HVAC, process equipment.
• Manage process and equipment transfer from the existing site.
• Manage external CQV resources, engineering contractors and equipment vendors.
• Own facility and equipment URS, vendor FAT and SAT.
• Collaborate with quality to prepare QMS, documentation and regulatory registration.
• Report progress, risk and timelines to senior stakeholders.

Skills

CQV leadership

IQ/OQ/PQ

PPQ

ISO 13485

21 CFR 820

Vendor management

Capital project budgeting

Coating / web handling

On-site Wisconsin work

Job description

CAPU Search is supporting a medical device manufacturer with a new Wisconsin site build, seeking a Site Qualification & Validation Lead to own the CQV program end-to-end. You’ll plan, supervise contractors, and ensure the facility is qualified, audit-ready, and on schedule.

The role emphasizes ownership over commissioning and qualification strategies, PQ through to transfer, and collaboration with quality to achieve ISO 13485 and 21 CFR 820 compliance for a regulated manufacturing environment.