Pacific Bioscience Laboratories, Inc. Job Description
Director, Quality Systems & Assurance
This position is responsible for designing and implementing Quality Management System (QMS), ISO 13485 compliant, for an FDA regulated consumer products company, with products including electronic devices and OEM consumable products, supplied to both to US and International markets. Also, responsible for product quality assurance.
REPORTING Reports to the AVP, Quality
DUTIES AND RESPONSIBILITIES
Develop and manage Quality Systems and Assurance organization
Cooperate with peers and vendors on quality issues
Participate in preventing and solving quality problems both in existing and developing products
Advise in development of business systems and processes beyond product quality management
Assure compliance with FDA and other regulatory agencies
Ensure compliance to the Quality Management System (QMS) and obtain/maintain ISO 13485 certification
Manage and ensure compliance for the Corrective and Preventive Action (CAPA) program in accordance with ISO 13485.
Manage QA internal audit function, ensuring compliance with written procedures, regulations and standards are maintain throughout the organization
Manage the Document Control function, ensuring integrity in life cycle management of products.
Manage both the US and International Complaint process, coordinating QA analysis and ensuring timely responses.
Manage the Employee QMS Training process, ensuring that employees trained to appropriate procedures, standards and regulations, in a timely and effective manner.
Responsible for the continual collection and analysis of QMS data, to ensure the health of the QMS.
Responsible for the Management Review system; to include data collection, scheduling, and meeting minute generation.
Serve as the Management Representative in accordance with ISO 13485. Serving as primary contact and Audit Host for regulatory audits, follow-up and closure activities.
Technical degree, desirably in electrical or mechanical engineering, with design or manufacturing engineering experience preferred
10+ years experience involving the full range of QA activities, including design for reliability, product assurance, vendor management, production quality assurance and control, and reliability engineering
10+ years' experience in a regulated environment; to include audit experience; Advanced knowledge of ISO 13485:2016 or equivalent required
Direct experience at interfacing with FDA and/or other such regulatory agencies
Experience at planning and leading an organization through ISO 13485 certification
Successful experience at supervising and developing a QA operation, including budgetary management
Experience dealing with quality management of both domestic and foreign suppliers
A track record of making financial contributions through quality management
Ability to work effectively and cooperatively with other departments
Strong interpersonal and communication skills
We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
If you require a reasonable accommodation to complete an application for a recognized disability under applicable law, please email USApplicationAccommodation@support.lorealusa.com. Please note this email will only respond to specific requests for assistance completing the application as a request for accommodation for a disability. All others will not be considered.
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