In this role you will provide support to ensure the organization is in compliance with the legal, regulatory and standards requirements for the quality system (ISO 9001) and applicable procedures in the area of Operations in Latham factory as well its local and global interfaces. You will also ensure product compliance according applicable standards and requirements prior to distribution to Philips system manufacturing facilities while driving continuous product quality and process improvement.
You are responsible for
Ensuring that appropriate quality plans (QDS) are made that include all stages of the life cycle of the product and supports Quality Plan design
Providing effective oversight of the execution of the Quality Plan, any Risk Management activities, and all design related activities during the product/system lifecycle
Performing independent technical assessment of product quality performance and post-market product quality analysis
Leading quality related problem solving and root cause analysis during design and manufacturing
Using post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams).
Producing and completes Quality Engineering documents. Normally receives general instructions on routine work, detailed instructions on new projects or assignments
Performing timely, detailed quality engineering tasks like:
Assessing product designs
Reviewing test and other performance data
Analyses of market complaints
Completing or assisting with root cause analysis and quality problem solving.
Interacting frequently with management and peer groups.
Working on issues where analysis of situation or data requires review of relevant factors. Exercises judgment within defined procedures and policies to determine appropriate action.
You are a part of the Philips Healthcare Product Quality Assurance team in Latham NY. Our global Healthcare team provides opportunities to develop your career in a variety of ways; work on global team projects, work with business leaders and influencers to drive change, improve health outcomes and deliver meaningful experiences for patients and families. Our passion in Healthcare will tap into your innovation with new experiences & desire to make a real impact on our customer’s personal health.
To succeed in this role, you should have the following skills and experience
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
5+ years of Quality Engineering experience in a regulated environment, preferably within Medical Device.
Bachelor’s degree in a scientific discipline, Engineering preferred. (Associates degree with added experience acceptable)
Independently produces and completes Quality Engineering Documents. Can develop & administers quality related project plans and schedules.
Responsible for performing timely, quality engineering tasks like:Assessing quality plans and product designsReviewing test and other performance dataAnalyses of market feedbackLeading root cause analysis and quality problem solving.
Individual contributor who acts as mentor to junior team members on quality related projects or issues.
Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions
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.