Quality Management Systems, Lead

Summary

Support and improve policies and procedures to the company's quality systems.

Job Responsibilities

• Provide support to maintain the Quality Management System in accordance with the standards required by the industry (ISO 13485 / ISO 9001).

• Provide support to the internal quality audit program (Lead auditor and/or auditor)

• Supervise and control the results of audits by external bodies related to product quality.

• Follow-up on corrective and preventive actions (CAPA).

• Performs process compliance audits.

• Control of the document control system.

• Ensure compliance with QMS policies and procedures.

• Induction Support (regarding Quality Management systems)

Job Essentials

• Ensure the implementation of all relevant procedures described in the Quality Management System

• Control of company documents such as manuals, procedures, instructions, policies, formats (registrations, cancellations and updates)

• Review of the actions of the scheduled audits

• Review of CAPAs (formatting and verification of effectiveness)

• Weekly follow-up to LAYERS/Customer Complaints

• Support in the analysis of the findings of external audits and the implementation of corrective and preventive actions

• Support for audits by regulatory agencies

Marginal Elements of Work

• Participation/support in external audits

• Support in answering assessments (questionnaires) sent by the client

• Audit of records used in the different areas

• Detect, inform, help develop and implement improvement actions

• 5s in the workplace

Qualifications

Education/Work Experience

• High School Diploma

• Minimum 2 years' experience in the management of quality management systems

Skills/Knowledge

Knowledge of team roles in the manufacture of electronic assemblies

Knowledge of internal audits and projects

Development and management of engineering and manufacturing process flows

MS-Office Management (Excel, Power Point, Word)

Internal Auditor in ISO-9001 or ISO-13485

5S's

Analysis of problems and knowledge on the development of corrective and preventive actions and implementation

Understand the requirements of regulatory agencies such as UL, TUV, CSA, NOM, etc.

Knowledge in the management of document control

Maintain communication in English (written and spoken)

Benefits Offered: Comprehensive benefit package including medical, dental and vision coverage; company-paid basic life/AD&D insurance, short-term and long-term disability insurance; voluntary supplemental insurances, flexible spending accounts and employee assistance program (EAP). Sick Leave, Vacation Time, and company-paid Holidays are also provided as paid time off. NEOTech also provides a 401(k) Retirement Savings Plan option with a company match.

NEOTech is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

NEOTech has a long-standing commitment to maintaining a safe, quality-oriented and productive work environment. We also want all employees to perform their duties safely and efficiently, in a manner that protects their interests and those of their co-workers. We recognize that alcohol and drug abuse pose a threat to the health and safety of NEOTech employees and to the security of the Company’s equipment and facilities. For these reasons, NEOTech is committed to the elimination of drug and alcohol use and abuse in the workplace. Candidates being considered for hire must pass a pre-employment background check and drug test which include screening for illegal drugs and marijuana.