Supplier Quality Engineer

Location: New Kensington, PA

Job Title

Supplier Quality Engineer

Job Description

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

This position resides in the Sleep & Respiratory Care Business Group, a business group of Philips HealthTech. We are highly dynamic, ambitious and agile within a fast changing industry.

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.