In this role, you have the opportunity to
Perform Supplier Quality activities related to purchased part qualification with suppliers, supplier quality issue resolution and ensuring appropriate incoming material inspection strategies. Partner with Product Development and Manufacturing to adequately define Critical to Quality (CTQs) purchased parts. Plan, execute, and manage quality activities with suppliers, setting a high standard and fast response expectation so quality issues are prevented or minimized. Lead with best practices to enable our organization to provide high quality medical products to our customers.
You are responsible for
Independently Produces and completes Supplier Quality Engineering related activities and documentation.
Completes Qualification of materials and components (including spare parts), development/ improvement of supplier processes for CtQ's, supplier process control plans; ensuring that the supplied part meets specifications, and the control limits/tolerances for CtQ parameters are met.
Qualifies and sustains sub-processes of suppliers, including performing process validations for critical supplier processes impacting part quality.
Ensures that the components/products at the supplier (including spare parts and services) are released according agreed specification and quality requirements (MQA/APQP / PPAP), and SQ audit results.
Executes SCAR management, effective and timely closure and Review/risk assessment of QN's and their escalation to SCARs where needed.
You are a part of
The Sleep and Respiratory Team to support products such as Nebulizers, Spacers, and Peak Flow Meters.
Our vision is to work hand-in-hand with our clinical and consumer customers to transform the personalized healthcare market to meet the significant demands caused by the increase of chronic conditions and an aging society. Our mission is to improve the quality of life for consumers and patients through better awareness, diagnosis, treatment, monitoring, and management of their conditions.
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.
5+ years of total industry experience 3+ years of related experience in a medical device or regulated industry.
Current certification with a recognized Accreditation body (i.e., RAB-QSA/IRCA) or successful completion of ASQ certification as a Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) or Certified Biomedical Auditor or successful completion of a recognized Lead Auditor course is preferred.
Working knowledge of appropriate global medical device regulations, requirements and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
Experience in root cause analysis, corrective and preventive action methods.
Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.
Good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control Plans, etc.)
In return, we offer you
At Philips, we are encouraged by our mission to improve the lives of 3 billion people per year by 2030, 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.
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.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.