Job Description

Job Description

Job Description

Summary

Develops, implements and coordinates product assurance program to prevent oreliminate defects in new or existing products. Oversees compliance program to ensure company compliance to applicable domestic and foreign regulations and standards.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
1. Establishes, implements, and documents companywide procedures used to comply with Quality System Regulation, International Standards Organization and other applicable standards.
2. Directs interactions with FDA inspectors, Notified Body auditors and other quality system related agency/customer inspectors.
3. Reviews and approves corrective actions identified in support of the post-market surveillance, product vigilance and corrective/preventive action systems.
4. Performs or directs performance of audits of internal operations to assure QSR/ISO compliance.
5. Establishes training program and conducts regular employee training in QSR and ISO compliance.
6. Performs QA review of deviations and non-conforming material reports as well as review of validation and qualification documentation.
7. Conducts Management Review Meetings with executive management to establish, delineate and review quality program policies and goals, to review product and process performance and quality trends, to coordinate functions and operations between departments, and to establish responsibilities for attaining objectives.
8. Establishes statistical sampling procedures and record keeping systems.
9. Analyzes, evaluates, and presents information concerning factors such as quality trends, regulatory trends, business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products for consideration by other members of the management team.

10. Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
11. Cooperates with other top management personnel in formulating and establishing company policies, operating procedures, and goals.
12. Develops initial and subsequent modifications of product assurance/regulatory compliance program to delineate areas of responsibility, personnel requirements, and operational procedures within program.

13. Evaluates contents of reports from product assurance/regulatory compliance program and confers with top management personnel preparatory to formulating fiscal budget for product assurance/regulatory compliance program.

14. Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
15. Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards.
16. Confers with engineers about the quality assurance of newly designed and manufactured products as well as to rectify problems with existing products already on the market.
17. Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.

Supervisory Responsibilities

Directs four (4) subordinate employees. They are the Quality Engineer, MRB and Calibration Coordinator, Inspection Team, and Documentation Control. Responsible for the overall direction, coordination, and evaluation of this unit. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning and assigning work; appraising performance, rewarding, and disciplining employees; addressing complaints and resolving problems.

Competencies
Achieving Commitments
Customer Focus
Raise Standards
Bias for Action
Attitude
Teamwork
Impact vs. Activity
Performance
Technical Skills
Values and Ethics

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience
Bachelor’s degree (BS or BA) in a physical or life science, engineering or other technical discipline from a four-year college or university, with a minimum of 5 years related experience in a medical device or oxygen/nitrogen device producing RA/QA organization.

Language Skills
Ability to read, analyze and interpret technical procedures, governmental regulations, professional journals, or general business periodicals. Ability to write reports, procedure manuals, and business correspondence. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.

Mathematical Skills
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Other Skills and Abilities
Ability to use various computer software applications applicable to this position including, but not limited to, spreadsheets, databases, word processing, computer assisted drawing, slide presentations, e-mail. Must be able to operate various pieces of testing and office equipment including voltmeters, calipers, copiers, facsimiles, calculators and other similar equipment.

Physical Demands
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to walk and sit. The employee is occasionally required to stand and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually low to moderate.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

PCI is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. PCI is also a federal contractor. Employment may be contingent upon U.S. citizenship or valid "green card" holder status.

This position requires use of information or access to hardware which is subject to the Internal Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e., 'Green Card Holder'), Political Asylee, or Refugee.

Pacific Consolidated Industries, LLC. is headquartered in Riverside, CA. The Company was founded in 1986 to supply cryogenic air separation systems to the U.S. military and has since expanded its technology offerings to include membrane and adsorption-based air separation. The Company has grown to become a leading manufacturer of rugged, mobile liquid and gaseous oxygen and nitrogen generation systems for the Military, Oil & Gas, and Commercial Oxygen markets. The Company has established itself as a global leader in air separation technology with thousands of systems installed in over 40 countries.

Company Description

Pacific Consolidated Industries, LLC. is headquartered in Riverside, CA. The Company was founded in 1986 to supply cryogenic air separation systems to the U.S. military and has since expanded its technology offerings to include membrane and adsorption-based air separation. The Company has grown to become a leading manufacturer of rugged, mobile liquid and gaseous oxygen and nitrogen generation systems for the Military, Oil & Gas, and Commercial Oxygen markets. The Company has established itself as a global leader in air separation technology with thousands of systems installed in over 40 countries.

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