Manager, Product Compliance

About the role

MKS Inc. is looking for a Manager, Product Compliance to own the execution and results of its product-compliance audits and certification-surveillance programs across assigned manufacturing locations. The role reports to the Director of Product Compliance and works with corporate compliance, quality, manufacturing, operations, engineering, supply chain, supplier quality and external laboratories and certification bodies.

Key responsibilities

• Own the product-compliance audits for assigned manufacturing sites and all certification activities, including 3rd-party audit readiness, timely closure of findings and controls that keep certified products aligned with approved constructions and regulatory requirements.
• Set 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 mitigate gaps before audits.
• Own compliance-critical manufacturing controls such as receiving inspection, calibration, production test records, document control and engineering/manufacturing change control, and evaluate changes for certification impact.
• Manage relationships with the compliance group, third-party laboratories, NRTLs/certification bodies, inspectors and technical reviewers.
• Plan and manage assigned third-party audit, certification and related services budgets.

Required profile

• 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.
• Able to influence senior stakeholders and cross-functional teams and to communicate clearly internally and externally.
• Willingness to travel domestically and internationally about 30% and to work in manufacturing, laboratory and supplier environments.

Required skills

• Knowledge of product safety and EMC/EMI standards such as IEC/UL/EN 61010-1, IEC/EN 61326-1, IEC/EN 60825-1, IEC 61000 series and SEMI S2.
• Knowledge of global compliance frameworks including CE marking, LVD, EMC, FCC, NRTL certifications, UKCA, KC, RoHS, REACH and China RoHS.
• Understanding of ISO 9001 and internal auditing principles.
• Program-management discipline and strong written and verbal communication.
• Preferred: hands-on experience with UL, Intertek/ETL, CSA, TUV or similar NRTL inspections; ISO 9001 internal auditor or CQA certification; ERP, PLM and QMS systems; semiconductor, vacuum, plasma, RF/power, laser/optical or precision motion equipment.