A Medical Device packaging company in the Trevose, PA area is looking for a CAPA Team lead. This person will be have a hybrid of quality and customer service responsibilities. They will need to intake and manage Internal and Customer CAPA records in an effective and orderly manner. They will then need to perform investigations, risk assessment, FMEA assessments, hold meetings with stakeholders, and implement necessary change. This person will need to be highly organized as they will and comfortable in a fast paced environment, as they will be handling multiple cases and records at once. This person needs have a background and understanding of quality standards- preferably ISO-13485. He or she will need to have strong communication skills with customers and internal employees. They will also work closely in conjunction with this employee to make sure customer quality expectations are met and exceeded.
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* 3+ years experience in a quality related role in a manufacturing environment
* Strong root cause analysis (i.e. Flow charts, fishbone, six sigma, 5-Why, 8D, DMAIC)
* Strong knowledge and understanding of ISO standards (ISO 13485 is preferred)
* Experience leading CAPA's (Corrective And Preventative Action) or Audits
* Very Detail oriented and organized
* Strong customers service and interpersonal skills
* Capable of strategizing and implementing effective change across multiple departments
* Background in medical device industry (or other regulated industry)
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.