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Quality Manager

3 months ago

New York, United States ADDMAN Full time

POSITION SUMMARY:

The Quality Manager at ADDMAN - HARBEC will work to apply knowledge in the implementation of an integrated Quality Management System (QMS) to ensure full compliance and a continual product, process, and supplier improvement culture. This individual will work closely with all cross-functional teams to create quality strategies that support customer needs and overall business objectives. Work on and provide solutions to a wide range of difficult problems relating to the quality aspects of design, validation, and manufacture of medical devices. The Quality Manager serves as owner and administrator of several aspects of the quality system, including but not limited to supplier management, customer feedback, process control, internal audits, change management, and design control. This quality and compliance professional will be responsible for assuring conformance to product serve as the sites lead ISO Representative.

This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen or U.S. Permanent Resident.


ESSENTIAL JOB FUNCTIONS:

  • Plans, implements, and directs quality program consistent with ISO and AS9100 quality systems.
  • Maintains and communicates quality objectives complementary to corporate policies and goals.
  • Maintains a working knowledge of government and industry quality codes and standards.
  • Assist in daily quality related requirements on the shop floor; such as in process and final inspection of parts and assemblies.
  • Develops and directs internal audit program, customer audits, certification audits, and audits vendors/suppliers. Works to resolve issues and non-conformances found during audits.
  • Leads investigations of customer complaints and ensures that corrective actions are implemented in a timely manner. Communicates with customer as required.
  • Leads investigations of internal non conformance and ensures that root cause corrective actions are implemented in a timely manner and treated with the same importance as a customer complaint.
  • Leads efforts to reduce quality issues including corrective action, preventive action and supplier quality concerns.
  • Ensures purchases of materials meet customer requirements.
  • Works with Manufacturing and Quality Engineers in the preparation of Quality Data Packets.
  • Has active role on quality control team, leads team in document and data control.
  • Promotes a positive and professional work environment.
  • Leads and records company’s quality management review meetings.
  • Serves as the liaison with 3rd party auditing and evaluation organizations.
  • Monitors the approved supplier and supplier evaluation processes.
  • Manages the process integrity/data collection processes and reporting to senior management.
  • Oversees the customer satisfaction and evaluation process.
  • Monitors laboratory processes and effectiveness.
  • Utilize six-sigma quality tools, when appropriate, to define, measure, analyze, improve and control processes and outcomes.
  • Responsible to maintain & support processes, procedures & K.P.I.’s owned by your position.


Requirements

QUALIFICATIONS:

  • A bachelor’s degree in industrial management, quality management or related field.: three to five years related experience and/or training; or equivalent combination of education and experience.
  • Demonstrate effective interpersonal and communication skills.
  • Experience with ISO and/or AS9100 quality systems, quality planning and mechanical inspection
  • Previous supervisory experience, quality function preferred.
  • Demonstrate organizational and analytical skills.
  • Ability to read and interpret documents, write reports and correspondence, and convey appropriate message to vendors, customers, and employees.
  • Demonstrate the ability to manage risk and resolve conflict.
  • Must be able to resolve complex manufacturing problems and troubleshoot manufacturing/production systems.
  • Ability to apply your knowledge of mechanical engineering, machining, metrology instrumentation and experimental techniques in developing customer solutions.
  • Experience and knowledge with ASME Y14.5.
  • Experience with PC DMIS
  • Experience with Epicor or other ERP system
  • Experience with special processes i.e., plating, welding, heat treat, etc.
  • Knowledge of CMM, and injection molding
  • Experience with Supplier Certification and Supplier Quality Planning
  • ASQ or similar professional certification
  • Working knowledge of quality improvement tools, including Six Sigma