Director – Mechanical Quality Assurance (ASME, 3-A)

The Director – Mechanical Quality Assurance (ASME, 3-A) is a senior leader responsible for managing and enforcing mechanical QA programs that ensure compliance with ASME pressure vessel codes, 3-A sanitary standards, and other applicable regulatory or customer-specific requirements. This role provides strategic direction, technical oversight, and continuous improvement leadership for the quality assurance of mechanical systems, process equipment, piping, and fabricated components.

The ideal candidate brings deep expertise in pressure vessels, sanitary design, and mechanical inspection processes, with a proven track record of leading QA/QC teams in highly regulated industries such as pharmaceuticals, food and beverage, biotechnology, or industrial manufacturing.

Key Focus Areas:

1. Compliance with ASME Code, 3-A Standards, and Industry Regulations

2. Mechanical Quality Management System Oversight

3. Inspection and Documentation of Process Equipment and Piping

4. Team Leadership and QA Personnel Development

5. Customer and Regulatory Audit Readiness

Key Responsibilities:

1. Mechanical QA Program Leadership

• Develop and oversee mechanical quality systems aligned with ASME Section VIII, B31.3, and 3-A standards.

• Define inspection criteria, acceptance protocols, and documentation requirements.

• Ensure quality is embedded at all stages—from design review to final acceptance.

2. Compliance Management

• Ensure product and process compliance with regulatory bodies (FDA, USDA, ISO, 3-A SSI).

• Approve weld procedures, NDE programs, and pressure test protocols.

• Monitor and maintain up-to-date knowledge of changes in relevant codes and standards.

3. Equipment and Fabrication QA Oversight

• Oversee inspection of pressure vessels, heat exchangers, hygienic piping, and skidded systems.

• Manage quality documentation including MTRs, DQ/IQ/OQ, weld maps, and test reports.

• Lead root cause analysis and corrective action efforts for non-conformances.

4. Audit and Certification Management

• Prepare and lead third-party and customer audits for ASME U-stamp, 3-A symbol authorization, and internal compliance reviews.

• Manage internal audit schedules and ensure continuous audit readiness.

• Serve as the primary contact for certifying agencies and standards organizations.

5. Team Development and Cross-Functional Leadership

• Lead and mentor quality engineers, inspectors, and document control personnel.

• Work closely with Engineering, Manufacturing, and Project Management to support a quality-first culture.

• Provide training on sanitary and mechanical QA topics, including ASME and 3-A expectations.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Quality Engineering, or related field (Master’s preferred).

• 10+ years of QA experience in mechanical or process equipment manufacturing.

• Deep understanding of ASME Code (Sec VIII, B31.1/3) and 3-A Sanitary Standards.

• Certified Welding Inspector (CWI), ASQ Certified Quality Engineer (CQE), or equivalent is a strong advantage.

Preferred Skills:

• Familiarity with fabrication of sanitary process equipment and hygienic piping systems.

• Strong experience with non-destructive examination (NDE), hydrostatic/pneumatic testing, and pressure certification.

• ERP and QA software knowledge (SAP, MasterControl, etc.).

• Excellent documentation, reporting, and communication skills.