Quality Engineer
In this role you
You are responsible for guiding the implementation of advanced process validation strategies, utilizing statistical tools to ensure new products transition seamlessly into production while meeting stringent quality and regulatory standards.
Your role:
• Develops and guides implementation of comprehensive process validation strategies, employing advanced statistical tools to ensure the seamless and compliant transition of new products into production, meeting both stringent quality and regulatory standards.
• Leads the entire design control process, from eliciting and validating design inputs to managing verification, validation, and design transfer activities, ensuring rigorous adherence to global regulatory requirements and quality standards across all product development stages.
• Leads strategic quality improvement initiatives by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all stages of the product lifecycle, continuously enhancing product quality, reliability, and regulatory compliance.
• Conducts comprehensive assessments of product and system designs, critically reviewing performance data and leading root cause analyses to identify and rectify quality deficiencies, ensuring that design excellence is maintained and regulatory standards are met.
You're the right fit if:
- Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent
- 3+ years of experience in Process Quality Management, CAPA, Medical Device manufacturing, Continuous Improvement.
- Experience in applying 21 CFR 820, ISO 13485, IEC 14971 and IEC 62304 and working knowledge with IEC 60601 and other relevant medical device standards
- Experience with large Electro-Mechanical equipment, New Product Development.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
This is an office role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Learn more about our culture.
Philips Transparency Details
The pay range for this position in Latham NY is $87,000 to $126,000 Annually.
The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.
In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.
At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.
Additional Information
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Latham NY.
#LI-PHI
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.
Top Skills
What We Do
Do the work of your life to help the lives of others.
As a leading health technology company, it is our purpose to improve people’s health and well-being through meaningful innovation. Our goal is to improve 2.5 billion lives per year by 2030.
We also strive to be the best place to work for people who share our passion, by promoting personal development, inclusion and diversity while acting responsibly towards our planet and society.
