Director of Quality Assurance

Vital Connect Inc•San Jose, CA

7d•$200,000 - $230,000

About The Position

This position provides leadership for the development, implementation, communication, and maintenance of quality systems policies and procedures for VitalConnect. Additionally, this position is responsible for documentation control, receiving and in-process inspection, finished product release, calibration, preventive maintenance, employee training, and other quality initiatives.

Requirements

Bachelor’s degree
8 years of experience in a medical device company
Management experience required
Ability to deal effectively with all levels within the organization as well as external parties, including regulatory bodies

Responsibilities

Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the quality assurance function.
Oversees the generation, review, and approval of Standard Operating Procedures and Work Instructions relating to Operations and Quality.
Serve as a liaison and partner with the Management Representative for audits, communication, and interactions on behalf of VitalConnect.
Develop, implement, communicate and maintain the Company’s Quality Management Systems and Policies into compliance with ISO and FDA requirements.
Manage documentation related to Quality System, ISO and FDA guidelines.
Provide leadership for developing and directing Quality Assurance and quality improvement initiatives for all products and services.
Assess improvement initiatives resulting from all Quality Audits, internal and external. Oversees the planning and execution of internal audits of documentation, records, and systems and assess improvement initiatives resulting from all Quality Audits, internal and external.
Effectively interact with Manufacturing and Product Development teams to maintain product supply and help introduce new products.
Manage and maintain the company’s quality inspection and product release programs for incoming and in-process materials and components and finished goods.
Report on a timely basis on the performance of the quality system, any non-compliance issues and recommended actions.
Manage the Quality Assurance staff.
Support the Operations/Production functions to assist in fulfilling customer orders.
Oversees quality system training and the maintenance of employee training record files.