Philips Quality Assurance Engineer in Monroeville, Pennsylvania
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Provide QA resource to product support to ensure regulatory compliance of post market products.
Ensure that projects to develop medical devices follow applicable company policies, procedures, standards and regulations.
Ensure that released devices are safe and effective and meet their intended use.
Assist in production and market of product in investigating and reporting the results of investigations for reported technical problems as part of corrective actions.
Support the investigation of vigilance and reportable events and reporting of the results of the investigations to corporate and regulatory authorities.
Travel to assist in customer, internal and supplier audits where required either in the UK or internationally.
Manage auditing of internal and supplier quality systems to ensure effectiveness of the quality management system.
Assist in improving the culture of all staff in Quality & Regulatory requirements of the Medical Device Requirements.
Support the QARA Manager in quality and regulatory decisions as required and other relevant tasks as may be reasonably requested of the QARA Manager.
Manage safety risks associated with medical devices in accordance with applicable standards.
Facilitate usability analysis and activities in accordance with applicable standards.
Represent QA on product defect review boards, and change control boards.
Help coach project teams on use of quality system.
Prepare for and participate in project and quality systems audits and inspections.
Proactively participate in design reviews, quality business reviews and post market improvement teams.
Support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.
Assist in investigating and reporting the results of investigations for reported technical problems as part of corrective actions.
Provide risk management and design control guidance for design quality assurance activities on medical device projects and coordinate quality activities with engineering, clinical, sourcing, manufacturing, distribution, service, and support teams.
To support the worldwide regulatory requirements through product submission, registration and continued compliance through complete life cycle of medical devices.
To provide regulatory and quality input for medical device products from generation through release to obsolescence assisting in planning, developing and quality support in projects.
To support quality control requirements, supplier quality, complaints, post market support, audit, non-conforming materials, CAPA systems and process risk.
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
You will report directly to the Manager of Quality Engineering for Philips Sleep & Respiratory Care (SRC) team. SRC is one of the businesses within Philips Patient Care & Monitoring Solutions (PCMS) division.
Location : This position is in Monroeville, PA.
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
We are looking for
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
Knowledge of 13485 / 9001 / FDA / Canada / 14971/ standards
FMEA/ Root Cause Analysis/ Problem solving
Interaction with different functional groups.
Call to Action / Contact
Find out more info about Philips at www.philips.com/na/careers .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.