The Senior Quality Engineer-CAPA will play a critical role within Philips’ Sleep & Respiratory Care Quality organization by providing guidance and expertise for all aspects/stages of the Corrective and Preventive Action (CAPA) workflow.
Your role:
Will review product/process Corrective and Preventive Actions (CAPAs) in various stages of the CAPA workflow.Facilitates CAPA investigations from issue identification through implementation of solutions, performs effectiveness monitoring and supports 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.Will manage projects involving all aspects of CAPA activity, including scheduling CAPA team meetings, ensuring CAPA deliverables per project timelines, and leading/ mentoring cross-functional teams with the implementation of appropriate root cause analysis techniques.Will analyze quality monitoring data sources, apply statistical techniques to identify existing/potential causes of non-conformances and perform periodic trend analysis and corrective action effectiveness measures of all quality system events to identify opportunities for improvement.Will work with all levels of management to ensure CAPA action plans can be supported, ensure costs/resources needed to implement the plan are available and support/prepare spokespersons in representing CAPAs during audits and CAPA Review Board meetings.You're the right fit if:
You have a minimum of 5+ years’ experience within FDA regulated medical device Quality environments, with a focus on CAPA reviews, investigations, root cause analysis, action plans and managing projects in all stages of the CAPA workflow.You’re able to understand/analyze complex problems, including software/hardware design issues and have demonstrated knowledge of the tools/techniques required to perform thorough root cause analysis and develop strong investigations.You have proven experience in data analysis/applying statistical techniques to analyze non-conformance, trending, KPI’s/performance metrics to identify opportunities for improvement.You have detailed knowledge of medical device regulations, requirements, and standards, such as 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), and Japanese MHLW Ordinance 169.You have strong communication skills, with the ability to effectively partner with a business, interact with/influence employees and managers at all levels.You have a minimum of a Bachelor's Degree (REQUIRED) in Mechanical Engineering, Electrical/Electronic Engineering, Science or equivalent.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 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 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 New Kensington, PA is $87,000 to $139,200.The pay range for this position in Cambridge, MA is $97,440 to $155,904.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. 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.
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 New Kensington, PA or Cambridge, MA.This role may require travel up to 10%.#LI-PH1
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.