Operations Quality Team Manager

Job Title
Operations Quality Team Manager

Job Description

As an Operations Quality Team Manager, you will lead Q&R activities in the system plant as a PQE team manager. You will be responsible for driving product quality improvements by leveraging statistics and data analysis techniques to enhance processes. Your role will involve close collaboration with production, manufacturing engineering, and suppliers to ensure process control, quality assurance, effective failure analysis, and continuous improvement.

Your role:

Provide clear vision and strategy for the PQE team, ensuring alignment with organizational quality goals.
Build and develop the capabilities of the quality team, fostering a culture of continuous improvement and collaboration.
Lead MRB activities, periodic quality reviews, and provide actionable insights.
Lead “real-time” manufacturing line investigations, identify root causes of issues, and ensure the implementation of corrective actions through comprehensive reporting and follow-up.
Implement and monitor production and process controls, including Process Validation (PV), Equipment Qualification (EQ), Control Plans, and pFMEA.
Maintain compliance with ISO 13485, FDA regulations, and other relevant standards.
Prepare for and support external audits (regulatory, customer) and perform internal pre-audits.
Act as a liaison between R&D and Operations to ensure a smooth transition during NPI and change management And work closely with Production, Supply Chain, and Manufacturing Engineering to improve overall quality performance.

You're the right fit if you have:

Bachelor's degree in engineering, production technology, science, quality assurance, mechanical engineering, or other related field.
A minimum of 3 years of experience as a quality manager or in a similar role.
A minimum of 5 years of experience as a product quality engineer
In-depth knowledge of quality assurance methodologies, standards, and regulatory requirements (e.g., ISO 13485, FDA, MDR).
Fluent in English, both written and verbal.

Advantage s

Experience working in medical device, pharmaceutical
Proficiency in statistical analysis tools (e.g., Minitab, JMP) and methods such as Six Sigma.
Expertise in quality systems, CAPA management, and risk assessment.
Familiarity with SAP or other ERP systems for quality tracking.
Experience in NPI (New Product Introduction) and production readiness activities.
Knowledge of advanced manufacturing processes, automation, and Industry 4.0 principles.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

Indicate if this role is an office/field/onsite role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business .
• Discover our rich and exciting history .
• Learn more about our purpose .

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here .

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