Senior Quality Manager-CAPA
Senior Quality Manager-CAPA
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$ 128000 - 205000
1 Vacancy
Job Description
Job Title
Senior Quality ManagerCAPAJob Description
The Senior Quality ManagerCAPA will play a critical role within Philips Global Patient Safety & Quality organization by leading and managing the Corrective and Preventive Action (CAPA) Program/Team for our global operations.
Your role:
- CAPA Program/Team Leadership: Will own/manage the global CAPA process ensuring timely identification investigation and resolution of quality issues. Oversees the root cause analysis process applying best practices such as 5 Whys Fishbone FMEA and other problemsolving methodologies. Ensures CAPA actions are effective sustainable and verified according to established quality system procedures. Develop and monitor key CAPA metrics (e.g. aging reports effectiveness checks) to assess program performance and identify areas for improvement.
- Global Quality Oversight: Provides strategic leadership and governance for CAPA activities across multiple regions ensuring consistency and compliance with corporate quality standards. Will collaborate with the CAPA Center of Excellence and other Quality Managers to align CAPA processes and share best practices. Serves as the CAPA subject matter expert (SME) during internal and external audits including FDA ISO 13485 and other regulatory inspections.
- Regulatory Compliance & Documentation: Ensures CAPA program adherence to global regulatory requirements including FDA 21 CFR Part 820 ISO 13485 MDR and other applicable regulations. Drives continuous improvement initiatives to enhance CAPA system robustness and documentation practices. Prepares and presents CAPA reports to senior leadership providing insights on trends risks and mitigation strategies.
- CrossFunctional Collaboration: Will partner with Service Sales Marketing Engineering Manufacturing and Quality teams to address systemic issues and implement effective preventive actions. Drives design for quality initiatives by integrating CAPA learnings into product development and manufacturing processes. Leads and mentors a team of quality professionals providing guidance on CAPA investigations and documentation.
Youre the right fit if:
- You have a minimum of 10 years experience in Quality Assurance/Engineering within FDA regulated medical device environments with proven functional leadership experience and expertise in CAPA program management root cause analysis corrective actions End to End QMS Post Market Surveillance Design Control and verification of effectiveness.
- You have Indepth knowledge of global medical device regulations (FDA ISO 13485 MDR) industry standards and experience in managing/presenting during regulatory audits.
- You have strong analytical/problemsolving skills with proficiency in quality tools and statistical analysis.
- You have excellent leadership communication and crossfunctional collaboration abilities.
- Youre experienced with electronic quality management systems (QMS).
- You have strong project management skills (MS Project preferred) with the ability to lead multiple initiatives simultaneously.
- You have a minimum of a Bachelors Degree (Required) in Engineering (Mechanical Biomedical Electrical) or a related technical discipline. Certified Six Sigma Green/Black Belt or ASQ Certified Quality Engineer (CQE) desired.
- 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 Officebased teams this means working inperson at least 3 days per week. Onsite roles require fulltime 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.
- 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 Nashville TN is $114000 to $183000.
- The pay range for this position in Cambridge MA is $128000 to $205000.
The actual base pay offered may vary within the posted ranges depending on multiple factors including jobrelated 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 longterm 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 workauthorized 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 Nashville TN or Cambridge MA.
- May require travel up to 10.
#LIPH1
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 drugfree workplace.
Required Experience:
Manager
Employment Type
Full-Time
