Director, Quality and Regulatory

Your Job

Phillips Medisize, a Molex Company, is seeking a Director of Quality Assurance, Regulatory Affairs & Compliance responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) and regulatory compliance infrastructure.

This role provides strategic and operational leadership across quality, regulatory, and compliance activities to ensure conformance with global regulations and customer requirements while enabling scalable, compliant growth.

As a key member of the leadership team, this role reports to the Vice President of Quality and Regulatory and will be part of the MPS division's Global Management Team (GMT).

Our Team

Phillips Medisize, a Molex Company is an end-to-end provider of design, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries.

The largest pharmaceutical, MedTech and in vitro diagnostics companies in the world count on Phillips Medisize to bring their breakthrough ideas and innovative branded products to market - with confidence.

As a contract design and manufacturing organization (CDMO), we work closely with our customers to deliver proven, highly engineered products that help millions of people live healthier, more productive lives including in vitro diagnostic devices, bioprocessing devices, autoinjectors, advanced, wearable injection pumps, and continuous glucose monitoring systems.

What You Will Do


* Lead the company's QA, RA, and Compliance team.


* Own and continuously improve the company's QMS in accordance with ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 210/211, IATF 16949, AS9100, and other applicable global regulations.


* Ensure effective document control, change management, risk management, and training systems.


* Drive continuous improvement initiatives using quality data, trend analysis, and risk-based decision making.


* Monitor regulatory changes and proactively assess impact to CDMO operations and customer programs.


* Ensure effective Quality Agreements and regulatory responsibilities are defined, executed, and maintained with customers and critical suppliers.


* Assist the Vice President of Quality and Regulatory in establishing strategic goals and objectives and deploying them successfully across the global team.


* Support external customer and notified body audits as needed within designated sites.


* Understand new and changing federal, state and local regulations that impact designated sites' regulated products and communicate changes appropriately to minimize regulatory risk.


* Work with Sales, Marketing, Program and Project Management to ensure that regulatory requirements and risk management are appropriately considered and accounted for in new programs and projects.

Who You Are (Basic Qualifications)


* B.S.

degree in quality, science, business, engineering field or technical field


* Ten (10) years or more experience in a quality role.
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