Senior Quality Engineer

Your Job

Are you an experienced Senior Quality Engineer looking to take the lead and have the ability to work autonomously in ensuring medical device excellence? At Phillips Medisize, we are dedicated to developing and delivering life-changing inhalation products. We’re looking for a Lead Quality Engineer (Quality Devices) to provide critical quality support to device development and industrialization, ensuring our products meet the highest standards of safety, compliance, and performance.

What You Will Do

As a Senior Quality Engineer, you’ll play a pivotal role in:

• Ensuring products are developed, transferred, and manufactured in compliance with industry standards and regulatory requirements.
• Driving quality excellence that directly impacts patients’ lives worldwide
• Partner with technical teams to ensure compliance with ISO 13485, ISO 14971, MDR, and FDA QSR requirements.
• Support and maintain Quality Management Systems.
• Develop and implement SOPs, protocols, and methods to ensure compliance with internal and external requirements.
• Perform internal and external audits, following up on non-conformances.
• Support supplier approval processes and maintain the Approved Supplier List.
• Manage corrective and preventive actions for both internal and external quality issues.
• Contribute to quality device KPIs and reporting.

Who You Are (Basic Qualifications)

You’ll bring:

• Experience in auditing, supplier quality management, and application of ISO 14971 Risk Management.
• Ability to evaluate/trend dimensional data and interpret technical drawings/specifications.
• Proven ability to drive improvements in quality systems (complaints, design control, CAPA, risk management, non-conformance).
• Excellent communication, engagement, and organisational skills.
• A proactive, calm, and flexible approach in dynamic environments

What Will Put You Ahead

• Experience in product development and commercial environments, including working with CMOs.
• Strong knowledge of quality engineering tools (AQQP, SPC, SCAR).
• The ability to work autonomously, bringing your few years of experience in industry to back you

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare

provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.