craigslist Jobs : Quality Assurance Manager (Santa Fe Springs, Ca. )

Quality Assurance Manager (Santa Fe Springs, Ca. )

Primary Job Title: Manager, Quality Assurance
Department: Quality Assurance
FLSA Status: Exempt
Prepared Date: 4/2/2012
SUMMARY
The Quality Assurance Manager shall provide overall leadership with respect to quality, and report directly to senior management. Responsibilities shall include training, calibration, CAPA, document control, process validation, receiving, and final inspection. The QA Manager shall ensure compliance with ISO 9001, 13485, 11135, 11607, 17665, and FDA QSR.

This position has the primary responsibility for the management of quality assurance activities as defined in the Quality Assurance Manual.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Serve as the Management Representative for Quality
Provide strategic planning for the quality system
Responsible for overall company compliance with ISO 9001, ISO 13485, ISO 17665, and FDA QSR
Coordinate in Management Reviews, Internal Audits, ISO Audits, Customer Audits, and as needed Regulatory Audits
Maintain California FDB Registration
Lead Quality Improvement Team
Administer the receiving, in-process, and final inspection programs at PRO-TECH
Manage the calibration recall system
Manage customer complaint system
Administer the Employee Training Program at PRO-TECH
Trend quality data and objectives
Complies with all Company policies and procedures, including safety rules and regulations
Understands PRO-TECH's Quality Policy statement
OTHER JOB FUNCTIONS
Other Duties as Required
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duties satisfactorily. The employee must demonstrate knowledge of computers, be capable of maintain accurate records, and make sound leadership decisions. The employee must be able to manage employee's effectively.
The employee shall be capable of reading and interpreting drawings and maintaining accurate records.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The associate must be able to understand, and interpret written instructions.
The employee must have specific experience and expertise in the following areas:
Quality Systems
ISO 9001, 13485, 11135, 11607, 17665, and FDA QSR
Medical Device Manufacturing/Cleanroom Operations
Sterilization
Process Validation
Calibration
EDUCATION AND/OR EXPERIENCE
Education and experience commensurate with job responsibilities
LANGUAGE SKILLS
Ability to read, analyze, and interpret written instructions and procedures
Ability to effectively present information and respond to questions from supervisors and managers
MATHEMATICAL SKILLS
Ability to accurately manage counts
Ability to perform simple math including addition, subtraction, multiplication, division, and percentages
REASONING ABILITY
Ability to interpret a variety of instructions furnished in written, oral, or diagram form
PHYSICAL DEMANDS
While performing the duties of this job, the employee is occasionally required to stand; walk; reach with hands and arms; talk or hear.
The employee must occasionally lift and/or move up to 30 pounds.
Specific vision abilities required by this job include close vision, and ability to adjust focus.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential function of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Location: Santa Fe Springs, Ca.
• Compensation: $50-$65K, Mon-Fri 8-4:30pm.
• Principals only. Recruiters, please don't contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.