Job Description

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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

* 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) null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.