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Global Director Supplier Quality Assurance
Philips
Nashville, TN, United States
Job Details - this job has expired, please see similar jobs below
In this role, you have the opportunity to
Ensure that purchased products and services meet the established requirements of the organization and that the purchasing and supplier processes align with all regulatory body regulations. Provides leadership and management support for the Global Supplier Quality Assurance team, including management of SQA’s assigned to the Global Systems and Process group. Driving collaboration across the SQA team and into the wider SQE group.
You are responsible for
• Lead Supplier Improvement and ensure Purchasing- and Supplier- management compliancy to FDA QSR 820 par 50 Purchasing Controls and ISO13485 section 7.4 Purchasing Controls for global markets.
• Develop and mentor SQA direct reports.
• Develop and implement Supplier Quality and Purchasing Controls processes, including linkages to Global Sourcing strategies and NPI that address the present and future needs of our internal and external customers.
• Set Quality system requirements to suppliers, including those for services, indirect quality relevant purchases , and QS requirements for suppliers in global markets; Lead and run assigned BG or Global SQA initiatives in partnership with critical partners Execute as the regional SQA lead in Markets when requested, aligning with BG SQA, SQE & SDE leads
• Contributes to developing a quality assurance strategy in line with supply management and business strategy with a 3-5 year sight line
• Assure execution of Quality oversight of Project book across BG as assigned
• Assure harmonized processes and systems are deployed to perform Qualification of suppliers’ QMS to the relevant medical device /drug (where applicable) quality regulations, and accountable for their placement on the Approved Supplier List , including required Purchasing Data elements of Supplier Master File; ensure processes for Project book oversight per RACI are established and executed
• Ensure robust supplier monitoring processes are deployed per established RACI and report key critical metrics per established processes
• Accountable for and leads the process for quality audits, re-audits and performance management at suppliers Accountable to drive Supplier QMS Qualification/re-qualification
• Accountable to ensure BG process for SQ critical metric reporting are effectively deployed and operationalized, including reporting L1 metrics
• Improve/develop quality management systems (supplier process improvement) at selected suppliers per business needs
• Develop purchasing controls processes and procedures, including those for BOM, non-BOM, services, spare parts and Markets, including their connection to other critical QMS processes such as Design Controls, Production and Process Controls, Traceability, Distribution, Complaint Handling, Installation, Services, 3rd party product risk assessments & Software
• Direct and lead the communication of critical shared BG and/or Market issues with broad SQA team for corrective and preventive actions
• Direct the development and delivery of training programs to internal teams and suppliers on Philips Purchasing controls;
• Supports on-site/off-site supplier quality development including coordination of required resources.
• Coaches and trains the SQ team in developing competencies and capabilities per procedures.
You are a part of
At Philips, we are inspired by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to build a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
Here at Philips we are Working Together for a Better Tomorrow:
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
To succeed in this role, you should have the following skills and experience
• Bachelor’s degree in an engineering or science discipline, or equivalent experience
• Current certification with Recognized Accreditation body (i.e., RAB-QSA/IRCA) ASC certification as a CQE and CQA or Certified Biomed Auditor or successful completion of a recognized Lead Auditor course.
• At least 15 years total industry experience with 10+ years of related experience in a medical device or regulated industry including 7+ years of management experience
• Working knowledge of appropriate global medical device regulation, requirements and standards such as 21 CFR Parts 803, 806 , and 820, ISO 13485, ISO 14791, and European Medical Device Directive (93/42/EEC), Canadian Medical Device Regulations (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001
• Authority Level Knowledge of methodologies, tools and techniques in Purchasing, Operations and SQ
• Strong people management skills and ability to work cross functionally
• Demonstrated success in effectively leading a quality organization, including a history of building a cohesive organization working collaboratively across all parts of the organization
In return, we offer you
The opportunity to contribute to culture-change and define processes within the organization. This position has the potential to be high-visibility and will collaborate with multiple partners.
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. 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 on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
Contact
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