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Quality Manager will manage quality assurance, control processes, and programs by developing, implementing, and administering quality standards and procedures assuring product quality, continual improvement, and customer satisfaction.
- Authoring/Creating all Quality System documentation (Reports, Protocols, Validations, Qualifications, Manuals, Procedures, Methods, Instructions, Analysis, etc)
- Controlling the Quality Management System including the Quality Manual, Procedures (QSP), Specification, Test Methods, and Work Instructions.
- Coordinating and documenting Management Reviews.
- Working with department leaders to ensure their personnel understand and consistently follow QSPs, Work Instructions and Test Methods.
- Working with department leaders to create, conduct, and document employee training, including new hires.
- Working with department leaders to ensure all aspects of Product Development meet all applicable regulatory requirements.
- Creating Design History Files and Technical Files.
- Approving product development quality system documents.
- Working with department leaders, complete CAPAs or NCRs, and Non-Conforming Records, ensuring consistency and compliance.
- Managing supplier evaluation and control.
- Maintaining contracts with OEMs and suppliers
- Working with department leaders to determine the need for and frequency of any Process Validations / Revalidations.
- Issuance of Work Instructions for production.
- Managing controlled documents in order to maintain FDA Approval, ISO Certification, CE Certification, MDSAP and other country medical device certification
- Obtaining and maintaining all product licenses and certification including FDA Registration, including 510(k), CE Mark and MDSAP records for new or existing products.
- Maintaining registrations/licenses and supporting OBL registration/license activities.
- Serving as Quality Management Representative.
- Controlling GUDID records.
- Managing internal, Notified Body audits. Facilitating FDA inspections.
- Reviewing all marketing & advertising communication for regulatory compliance.
- Bachelor’s degree
- At least 10 years’ experience in medical device industry managing a Quality System for FDA Class 2 devices, ISO 13485 Certification and CE Mark requirements.
- At least 3 years management experience.
- Highly proficient and accurate in writing and reviewing technical documents related to medical devices.
- Flexible for new assignments.
- Demonstrated ability as responsible for safeguarding confidential information.