In this role the Manager, Manufacturing Quality ensures and supports that the organization is in compliance with the legal, regulatory and standards requirements for the quality system (ISO 9001) and applicable procedures in the area of Operations in Latham factory as well its local and global interfaces. They will also ensure product compliance according applicable standards and requirements prior to distribution to Philips system manufacturing facilities. The function owner drives continuous product quality and process improvement.
You are responsible for
Leading and coaching Latham Product Quality team, DHR Acceptance specialist, DEFOA Manager and any other Quality functions in Latham operations area
Analyzing data, identifying improvement opportunities, prioritizing, communicating and delivering cross functional improvements to design, manufacturing processes and supplier quality
Leading Latham Global Operations Quality Management reporting
Creating and directing product quality and manufacturing improvement program
Identifying potential quality and safety related best practices for adoption
Accountability for effective design transfer from project teams for new product introductions
Ensuring the process for the design transfer, selection, process validation and calibration of production equipment is effective
Analyzing specifications and statistical data to develop procedures for quality and reliability requirements with respect to design and manufacturing processes
Creating a portfolio of measures, train Operations and Manufacturing Quality personnel on measurement methods, and ensure appropriate collection and reporting of the measures
Reviewing, deploying and releasing global operations related procedures to the local quality management system
Ensuring adequate design input for product creation and improvement
Accountability for control of non-conforming parts/products in Latham operations, defects identified during system and spare part installation (commercial & service DEFOAs) and addressing of adequate corrective and preventive actions (process, product, supplier)
Sponsoring and driving adoption of Lean, six sigma and other quality methods and initiatives in the area of product quality
Accountability for control and release of DHRs
Defining and monitoring product related quality data and KPI‘s, report Quality Results to the next level of management and Management Team
Training of employees in regard to the quality manual and related procedures
Planning, execution and support of external and internal audits
Support heads of Latham OPS and Q&R on assignments as needed
To succeed in this role, you should have the following skills and experience
Bachelor’s degree in Engineering discipline is required, Master’s degree preferred
5+ years of work experience in a manufacturing plant in medical device industry with key focus on FDA and European regulations
Needs to be familiar with business process classification framework including Industry practices such as APQP. Relevant training, experience and certification in continuous Improvement and transformation practices such as Lean/ Six Sigma, TQM, CTQ principles, DFX, Kaizen, Hoshin’s are highly preferred.
Capable of brain-storming, developing, coaching, and using key quality principles for trouble shooting and root cause analysis such as 5-whys, cause and effect (Ishikawa diagram), Is/Is Not, Pareto analysis and validated root cause hands-on experience to resolve timely issues with confirmed improved results.
Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.
Experience to include establishing global and systemic quality management system elements.
Possess and be able to demonstrate high performance behavior of shared accountability, listening and learning, sense of urgency, trust and influence management, self-growth and grow others.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.