Quality Engineer

Job Title

Quality Engineer

Job Description

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.

Youre the right fit if :

• Bachelors 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 / Remoteposition.

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 companys facilities. Field roles are most effectively done outside of the companys 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 wont 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.

Philips Transparency Details

The pay range for this position in Latham NY is $87000 to $126000 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.

Key Skills

APQP,Quality Assurance,Six Sigma,ISO 9001,PPAP,Minitab,Root cause Analysis,ISO 13485,Quality Systems,Quality Management,As9100,Manufacturing

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 87000 - 126000