Director of Quality Assurance in San Jose, California at Vital Connect Inc

Purpose

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

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.

Qualifications

• 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

Salary & Benefits

The estimated hiring salary range for this position is $200,000 - $230,000 * The actual salary will be based on a variety of job-related factors, including geography, skills, education and experience. The range is a good faith estimate and may be modified in the future. This role is also eligible for a range of benefits including medical, dental and 401K retirement plan.