Quality Assurance Director- Healthcare jobs in Simi Valley, CA

SUMMARY:

Responsible for the entire range of quality assurance activities in the organizational unit. Formulates and develops program design, policies and procedures. Issues formal product process specifications and confers with other top management, customers and other representatives in the planning, scheduling, coordinating and directing of the quality assurance program in conformance with customer requirements, engineering specifications, government regulations and production schedules.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop and implement a Business Management System that ensures compliance with all relevant regulations and standards, including AS9100, ISO 9001 and NADCAP
• Lead the Quality Assurance Team to ensure all product quality issues are addressed in a timely and effective manner
• Manage the Quality Assurance budget to ensure that resources are allocated appropriately and all department expenses are within budget
• Maintain and update all Quality Assurance documentation, including procedures, work instructions and forms
• Develop and implement a quality control system to monitor product quality and identify opportunities for improvement
• Provide leadership and guidance to the QA team to ensure that all employees are trained and equipped to perform their roles effectively
• Primarily responsible for internal audits, corrective actions and the associated follow-up actions.
• Accountable for keeping upper management informed of actions which may impact the Business Management System
• Schedule Management Reviews to verify the health of PTI's Business Management System
• Identify and implement KPI's needed to manage and improve the Business Management System

SUPERVISORY RESPONSIBILITIES:

Directly supervises employees in the Quality Assurance Department in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS:

• Previous Quality Assurance management experience preferably in an aerospace manufacturing environment.
• Strong written and verbal communication skills.
• Ability to make independent judgments and decisions in matters having an important influence on company image and product reliability.
• Proficient in the use of MS Office Suite software including Word, Excel and PowerPoint.
• Experience with ERP Quality management system, Oracle based preferred.
• Strong understanding of Cost of Quality and ability to manage toward improvement.
• Experience with Supplier Quality Management including corrective action system, supplier scoring, corrective action plans and management thereof, supplier assessments and audits for general capability, production readiness and project specific.

EDUCATION and/or EXPERIENCE:

A Bachelor's of Science Degree in Engineering or other related technical fields required; with a minimum of five(5) years of Quality Assurance experience in the manufacture of mechanical valves and filters, or an equivalent combination of education and experience.

LANGUAGE SKILLS:

Ability to effectively communicate with other divisions in order to achieve quality objectives. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to create routine reports and correspondence. Comfortable speaking effectively before groups of customers or employees of organization.

MATHEMATICAL SKILLS:

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

PHYSICAL DEMANDS:

Majority of work is performed in a typical office environment with no major sources of discomfort. Essentially a normal controlled working environment with noise levels within acceptable safety limits and acceptable lighting and temperature conditions. On occasion may be required to enter production/receiving area where the employee may be exposed to moving mechanical parts and/or fumes or airborne particles. Noise level in plant and/or shop work area is usually moderate.

WORK ENVIRONMENT:

Majority of work is performed in a typical office environment with no major sources of discomfort. Essentially a normal controlled working environment with noise levels within acceptable safety limits and acceptable lighting and temperature conditions. On occasion may be required to enter production/receiving areas when the employee may be exposed to moving mechanical parts and/jr fumes or airborne particles. Noise level in plant and/or shop work area is usually moderate. Proper safety training and equipment is provided to employee for the safe performance of required duties.

This description indicates the general nature of the tasks and responsibilities required of positions given this classification. It is not intended as a complete list of specific duties and responsibilities, nor is it intended to limit or modify the right of management to assign, direct and control specific duties of individuals performing this function. The Company reserves the right to change, modify, amend, add to or delete from any section of this document as it seems, in its judgment, to be proper. This description supersedes any previous description for this position.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.