Capa Coordinator

A Medical Device packaging company in the New Britain, PA area is looking for a CAPA Coordinator. This person will have a hybrid of quality and customer service responsibilities. This person will act as the administrator of the customer complaint process. They will need to intake and manage customer complaints in an effective and orderly manner. Ensuring that there is proper documentation and that proper investigation performed to validate the customer complaint. This person will need to work cross functionally with various teams within manufacturing to conduct investigations, as well as assist in the implementation of necessary corrective action. They will need to ensure that the quality department is always audit ready and that documents are properly filed. This role will require very strong written and verbal communication, as it will involve both customer and internal communication.
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 com.
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Background in medical device industry (or other regulated industry)
Bachelors Degree
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)
3+ years experience in a quality related role in a manufacturing environment
Experience engaging in quality audits or investigations
Experience with quality documentation control
Strong written and verbal communication