QA Manager
BioPhase Solutions - San Diego, CA

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BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a QA Manager to work for a leading San Diego biotechnology company.

QA Manager

Provides support during the design and development process to ensure compliance with the company’s quality system and applicable regulations. Ensure company wide compliance (establishment, implementation, and effectiveness) with the Quality System, GMP, and ISO regulations and standards. Manage the CAPA programs, which may include product complaint management and internal audit programs. May maintain and develop personnel training systems. Support Quality System reporting to management.

Facilitates the coordination of management teams to formulate new programs, company policies and operating procedures. Lead other management personnel to establish, delineate, and review organizational policies, coordinate functions and operations between departments and to establish responsibilities and procedures for attaining objectives.

Supports and facilitates the development, review and approval of new Quality System and Manufacturing documents and procedures to assure the compliance of the Quality Management System to relevant domestic and international regulations and standards.

In conjunction with other QA department management:
Manage CAPA programs designed to capture and resolve product and process quality issues. Identify and trend quality issues (Corrective Action Requests [CAR], and complaints). Support initiatives to drive continuous improvement.

Manage internal audit activities in conformance with the requirements of FDA QSR/ ISO 13485/ MDD 93/42/EEC and other relevant domestic and international regulations and standards, by ensuring the development and maintenance of audit schedules, audit planning and appropriate documentation of audit results and subsequent corrective actions (assuring the communication of the latter to the affected party), and maintaining an effective and compliant system to track completion of corrective actions to ensure they are implemented and determined to be effective. Support initiatives to address compliance trends and to facilitate continuous improvement.

Ensures constant readiness for compliance audits or inspections by regulatory agencies or quality system standards organizations, by ensuring audit and training programs are conducted, documentation for these programs is current, and that SOPs are reviewed periodically in a systematic fashion.

Ensures constant readiness for compliance audits or inspections by regulatory agencies or quality system standards organizations, by ensuring CAPA activities are conducted, and that documentation for these programs is complete and current.

Ensures the analysis and presentation of information to executive management concerning measures of product, process and service quality, manufacturing problems, training and audit activities and design issues as identified through various quality systems program elements.

Develop and maintain systems for the identification and performance of Quality System training, including training to Standard Operating Procedures. Ensures appropriate quality system training is conducted for all cGMP-impacted areas as applicable.

Other functions include the development of new quality initiatives, ensure quality system development and management remains in line with organizational objectives, including the development or organizational systems, procedure writing and review, and the management of initiatives designed to improve quality and reliability of products.

Reviews technical publications, articles, and abstracts to develop applicable skills and to stay abreast of quality, regulatory, compliance, and technical developments in the industry.

Responsible for attending such conferences, seminars, professional meetings, and other public forums as are relevant to the regulatory and quality interests of the company.

Supports other work of the Q.A. Compliance Department, as required.

Assist in the maintenance of federal Facility Registrations and Listings, and State Licenses.

Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.

Supervisory Responsibilities:
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; motivating, rewarding and disciplining employees; addressing complaints and resolving problems.


Computer Skills: Proficient and accurate with word processing (Word), spreadsheets (Excel), Outlook, IE Adobe Acrobat, and Visio, experience with SAP preferred.

Education and/or Experience: Certification American Society for Certified Quality Auditor (CQA) preferred. Must have knowledge of QSR and ISO 13485, MDD, and experience with medical device components. Familiarity with 21 CFR Part 11 Electronic Records; Electronic Signatures, and software validation. Experience in a regulated environment in Quality Assurance and or Manufacturing/Engineering (design) environment. A minimum of 5-7 years related experience in the medical device field is required. Bachelor’s degree is preferred.

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