Quality Management Systems, Lead (25942)

Reposted 11 Days Ago
Be an Early Applicant
92011, Carlsbad, CA, USA
In-Office
85K-95K Annually
Junior
Aerospace • Defense • Industrial • Manufacturing
The Role
Maintain and improve the Quality Management System under ISO 13485 and ISO 9001. Support internal, external, and regulatory audits; manage document control; review CAPAs and verify effectiveness; conduct process compliance audits; track customer complaints; support corrective actions and continuous improvement; and provide QMS training and induction support.
Summary Generated by Built In

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.

Skills Required

  • High School Diploma
  • Minimum 2 years of experience managing quality management systems
  • Knowledge of team roles in electronic assembly manufacturing
  • Knowledge of internal audits and projects
  • Experience developing and managing engineering and manufacturing process flows
  • Microsoft Office proficiency, including Excel, PowerPoint, and Word
  • Internal Auditor qualification in ISO 9001 or ISO 13485
  • Knowledge of 5S
  • Problem analysis and corrective and preventive action development and implementation
  • Understanding of regulatory agency requirements, including UL, TUV, CSA, and NOM
  • Knowledge of document control management
  • Written and spoken English communication skills
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The Company
3,000 Employees
Year Founded: 1991

What We Do

NEOTech is a premier provider of electronic manufacturing services (EMS), integrated design engineering, and advanced supply chain solutions. The company specializes in high-complexity, high-reliability programs for the aerospace and defense, medical device, and high-tech industrial markets. Their capabilities span the full product lifecycle, including microelectronics, PCBA manufacturing, cable and interconnect solutions, and system-level box build services.

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