Senior CAPA Engineer
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Job Location:
Orlando, FL - USA
Monthly Salary:
$ 87000 - 139200
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
Senior CAPA EngineerJob Description
The Senior CAPA Engineer will advise and critically review Corrective and Preventive Actions (CAPAs) and facilitate CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.
Your role:
- Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring
- Responsible for updating the business processes relating to CAPA
- 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 manages 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
- Represent CAPAs during audits and CAPA Review Board meetings
- Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques
- Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances
- Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement
Youre the right fit if:
- Youve acquired a minimum of 5 years experience in Quality Engineering within FDA regulated medical device environments with proven expertise in Corrective and Preventive Actions (CAPAs) to include facilitating CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.
- You have experience representing CAPAs during audits and CAPA Review Board meetings.
- You have experience in non-conformance root cause analysis and data/trend. Analysis.
- You have detailed knowledge of appropriate global medical device regulations requirements and standards including 21 CFR Parts 803 806 and 820 ISO 13485 ISO 14971 European Medical Device Directive (93/42/EEC) EU Medical Device Regulation Canadian Medical Devices Regulation (SOR/98-282) etc.
- You have a Minimum of a Bachelors Degree (Required) in Quality Engineering or related fields.
- You must be able to successfully perform the following minimum Physical Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together:
We believe that we are better together than a part. 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 of 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 Orlando FL is $87000 to $139200
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.
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.
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.
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 Orlando FL.
- May travel up to 10%.
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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.
Required Experience:
Senior IC
Key Skills
- APIs
- C/C++
- Computer Graphics
- Go
- React
- Redux
- Node.js
- AWS
- Library Services
- Assembly
- GraphQL
- High Voltage
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
