Quality Manager, Medical Devices
210 Welsh Pool Rd Franklin Ctr, PA 19341 US
Target Pay Rate: 60-68/hr **salary will be commensurate with experience
Develop and implement quality program with specific emphasis on Quality Systems, Verifications and Validations, Audits, Vendor Management, CAPA's, Complaint Handling and New Product Introduction for Combination Products. Ensure compliance to relevant Quality System Regulations for all quality system processes and procedures.
Provide direction and support for the CAPA process to ensure effective root cause corrective action is implemented to address nonconformance. Interface with all levels of management, functional areas and customers as they relate to CAPAs and the CAPA process.
Ensure robust execution of the complaint systems, MDR's (medical device [vigilance] reporting), internal documents and procedures in accordance with established by regulation/procedures.
- Develop and manage quality system in support of combination products/medical devices for client 60%
- Provide Quality Person in Plant support for products manufactured by client and contract facilities. 10%
- Provide quality support for Deviation Investigations and CAPA Management; Change Management, Contract Organization Approval/Monitoring Management and Complaints. 10%
- Perform additional quality support as needed. 10%
- Perform audits of External suppliers as needed. 10%
- A Bachelors degree in Life Sciences/Engineering discipline is required.
- Minimum 5 years experience in FDA or equivalent regulated industry (medical devices, biotechnology, or pharmaceutical industry).
- Minimum 4 years performing Quality Assurance functions related to medical devices/combination products, and minimum 2 years of experience performing audits for medical devices/combination products.
- Strong working knowledge of FDA, EMEA and JP regulations as they pertain to combination products/medical devices.
- Strong verbal and written communication skills both verbal and written
- Prior electronic systems knowledge required? (i.e., LIMS, Trackwise, SAP, MS Office, etc.)
- Domestic and International travel required
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