QUALITEL PROFILE:

Qualitel is an Electronics Manufacturing Service (EMS) provider that specializes in high end, high reliability product applications. The company invests heavily in people and technology to stay at the forefront of this field. The goal of Qualitel is to help its employees achieve self-sufficient, healthy and secure lives.

PRINCIPAL RESPONSIBILITIES:

Ensure Qualitel’s Quality Management System (QMS) complies with regulatory, corporate, customer, and specific quality requirements. Carries out these responsibilities in accordance with the organization's policies, customer requirements, and applicable laws (federal and or state). This will be accomplished by:

• Knowledge of the requirements related to ISO9001, ISO13485 AND AS9100, 21 CFR Part 820, Export Compliance and FAA regulations.
• Perform internal audits and generate corrective actions of non-compliant processes.
• Interface with external auditors and regulatory quality agencies, primary contact for all external audits of the quality system, escort auditors during on-site audits.
• Ensure CPA (Corrective and Preventive Action) system is properly maintained. Facilitate completion of CPA’s through use of cross functional teams.
• Write and submit audit schedule, plans and reports as required. Record, submit and maintain written results in accordance with stated requirements.
• Submit and maintain corporate regulatory and/or other registrations.
• Facilitate SPC/Corrective action meetings, as, needed, working with Quality Engineer, interpret condition of SPC charts, determine if any corrective/preventive action is necessary and assign appropriate individuals responsible for the correction action.
• Review documentation for release and that training, document relationships, supporting materials and regulatory considerations been made to ensure compliance with our QMS.
• Other duties may be assigned related to support of Quality Department.

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: Degree from four-year college or university; plus, minimum of five years related experience and/or training; or equivalent combination of education and experience. Auditor certification training and experience per the requirements related to ISO9001, ISO13485, AS9100, 21 CFR Part 820 required, Export compliance and FAA regulations. Experience with SPC systems.

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

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 sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, reach with hands and arms, and taste or smell. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

BENEFITS:

• Salary range: $24-$33/hour (DOE)
• Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge, skills, and experience
• Profit Sharing
• Bi-weekly Pay
• Compensation packages also include comprehensive benefits, 401K contribution and match, Flexible Spending Account (FSA), Medical, Vision, Voluntary Dental, Paid Time Off, Vacation, Paid Holidays and more