Job TitleSenior Quality Engineer- CAPA Expert
Job Description
Sr. Quality Engineer – CAPA Expert
In this role you
CAPA subject matter expert who can confidently advise and critically review Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow and facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.
Your role:
- Critically review product and process Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow
- Facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring
- Support updating the business processes relating to CAPA. Support and prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings
- Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving. Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines
You're the right fit if:
- Bachelor’s degree in an engineering or scientific-related field or other plus equivalent technical experience working in a medical device environment. 5+ years’ practical experience with CAPA
- Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations
- Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971
- Strong Project Management skills, including ability to project manage all CAPA activities
- 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 commitment to diversity and inclusion.
Philips Transparency Details
The pay range for this position In Cambridge is $89,000 to $127,000, 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 Cambridge MA
#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/Disabled/Veteran and maintains a drug-free workplace.
Similar Jobs
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.
