Mgr., Product Compliance

A Day in Your Life at MKS: (Summary & Objectives)

As a Mgr., Product Compliance at MKS Inc., you will:

• Own the execution & the results of the Product Compliance audits and certification-surveillance programs across assigned MKS manufacturing locations.
• Work with corporate compliance, quality, Mfg., Ops., Eng., supply chain, supplier quality, and external laboratories/certification bodies to establish clear action owners, due dates, escalation paths, and measurable deliverables.
  
  

In this role, you will report to the Director of Product Compliance.

You Will Make an Impact By: (Responsibilities)

Primary Objective - Product Compliance Audit Program Ownership

• Own the Product Compliance audits for assigned manufacturing sites and all certification activities. You will be accountable for 3rd-party audit readiness and execution, timely closure of findings, and the controls required to keep certified products aligned with approved constructions and regulatory requirements.
• Establish audit deliverables and hold Quality, Manufacturing, Operations, Engineering, Supply Chain/Supplier Quality, and suppliers accountable to committed dates; escalate missed commitments to site and business leadership, and ensure identified gaps are mitigated before the audits.
• Own compliance-critical manufacturing-control expectations, i.e., receiving inspection, calibration, production test records, document control, and engineering/manufacturing change control, product transfers, etc. related to CCL (Components Critical to Compliance List). Evaluate changes for certification impact, and complete agency notifications and technical reviews before implementation.
• Manage working relationships with MKS compliance group, third-party laboratories, NRTLs/certification bodies, inspectors, and technical reviewers.
  
  

Skills You Bring: (Required Skills)

• B.S. or M.S. in EE, ME, Quality Engineering, or a related technical discipline, with 7+ years of relevant experience in product compliance, certification, quality, manufacturing, or regulatory engineering.
• Demonstrated ability to influence senior stakeholders and cross-functional teams, establish accountability without relying solely on direct authority, and drive deliverables to closure.
• Excellent written and verbal communication skills with the ability to represent MKS effectively internally and externally.
• Working knowledge of product safety and EMC/EMI compliance requirements and standards such as IEC/UL/EN 61010-1, IEC/EN 61326-1, IEC/EN 60825-1, applicable IEC 61000 series standards, SEMI S2.
• Working knowledge of global product compliance frameworks and regulations, including CE marking, LVD, EMC, FCC, NRTL certifications, UKCA, KC, RoHS, REACH, China RoHS, and other applicable regional requirements.
• Strong understanding of manufacturing and quality-system controls relevant to certification audits, including critical components, engineering and supplier change control, traceability, doc control, calibration, inspection, and testing.
• Working knowledge of ISO 9001 and internal auditing principles, with the ability to interpret requirements, assess objective evidence, classify risk, and ensure findings are effectively closed.
• Strong program-management discipline, including prioritization, action tracking, resource planning, risk management, escalation, executive reporting, and management of multiple concurrent audits and certification commitments.
  
  

Preferred Skills

• Hands-on experience with UL, Intertek/ETL, CSA, TÜV, or similar NRTL/certification-body factory inspection
• Formal ISO 9001 internal auditor or lead auditor training; ASQ Certified Quality Auditor (CQA) is a plus.
• Experience managing supplier quality audits, supplier corrective actions, contract and global manufacturers
• Experience with ERP, PLM, and QMS systems used to manage BOMs, approved vendor lists, engineering changes, controlled documents, certifications, audit evidence, and CAPA records.
• Experience with semiconductor, vacuum, plasma, RF/power, laser/optical, precision motion, or other complex equipment.
• Experience managing third-party audit/certification budgets, service providers, or statements of work is a plus.
  
  

Key Interfaces

• Internal: Product Compliance, Quality, Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, Service, site leadership, and business-unit leadership.
• External: Third-party test laboratories, NRTLs/certification bodies, auditors/inspectors, suppliers, contract manufacturers, and other regulatory or certification representatives.
  
  

Supervisory Scope

• Reporting Relationships: Manager-level role with matrixed audit coordinators, as applicable to the organization structure.
• Financial Responsibilities: Responsible for planning and managing assigned third-party audit, certification, and related services.
  
  

Physical Demands and Working Conditions

• Able to travel domestically and internationally (30%) as needed to support manufacturing-site, supplier, laboratory, and certification audits.
• Able to work in manufacturing, laboratory, and supplier environments and comply with applicable site safety and personal protective equipment requirements.