In this role, you have the opportunity to
Provide quality engineer support to ensure that products are manufactured with a high level of quality, while being in compliance with standards and regulations governing medical device manufacturing.
You are responsible for
Understanding and applying FDA CFR 820, ISO 13485, ISO 14971, Canadian, Japanese, Brazilian and European medical device regulations.
Developing, reviewing and approving procedures, technical/validation reports, change notices, risk assessments, and other related quality system documentation.
Leading, supporting, or facilitating investigations, CAPAs, process changes, quality plans and other Quality activities.
Leading or supporting internal and external quality system audits. Drive resolution of nonconformities.
Managing quality engineering aspects of the transfer of new or existing products into the manufacturing facility.
Administering and manage delivery holds and reconciliations for assigned product lines. Provide support for field actions as needed.
Driving continuous improvement of products and processes to reduce the cost of non-quality (out-of-box failures, line yield, nonconforming material, and other available data).
Being team-oriented, communicate suggestions and concerns, generate solutions, be flexible, and provide positive interaction and feedback with peers and internal departments.
Innovation & change - While ensuring quality, look for ways to enhance effectiveness and efficiency of the organization's systems, processes and tools. Eliminate bureaucracy. Be flexible to change what is not working well.
Communications - Giving and receiving information in a business-like, informative, understanding, and instructive manner, both written and verbally.
Collaboration – Partner with manufacturing facility to inform, educate and problem solve in regards to QA processes
At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.
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.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
To succeed in this role, you should have the following skills and experience
BS in Electrical/Mechanical Engineering or science discipline
Preferred - ASQ Certified Quality Engineer or equivalent
3+ years in medical device industry, demonstrated understanding of, and ability to interpret regulations and guidelines governing medical device development
Demonstrated understanding and experience in applying modern quality engineering and management concepts (statistical competency, acceptance sampling, DOE, control and capability studies, FMEA)
Demonstrated understanding and experience with process validation methodologies (IQ, OQ, PQ), willingness to work as a team player in a change oriented department
Experience interacting directly with suppliers, Manufacturing and Manufacturing support organizations preferred
Excellent technical writing, communication, and organizational skills required, experience with MS Office products required, experience with a statistical software package is a plus
Excellent oral and written communication and interpersonal skills, ability to work independently and complete multiple assignments on time, required
Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That’s okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA .
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.