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Quality Manager (Medical)

This position will be hired by the company in the United States and work in the Tijuana facility. Valid work Visa or dual citizenship is required.

 

Summary: The Quality Manager plans, directs and coordinates the development, application, and maintenance of all quality systems for inspecting incoming product, raw material, in-process material and products through finish product. Oversees and directs plans, organizes and develops test plans, prepares test data and subsequent testing of all products. Responsible for managing data during product development and evaluation prior to product release. Responsible for customers, ISO audits, and for organizing compliance to regulatory requirements related to manufacturing medical devices.

Duties / Responsibilities:

  • Develops and documents quality plans for new and existing products.
  • Monitors and controls quality systems to ensure effectiveness, efficiency and compliance.
  • Manages incoming raw material inspection procedures and personnel.
  • Analyzes quality control test results and provides feedback and interpretation to production management or staff.
  • Supports manufacturing and engineering problem solving efforts on in-process and vendor related quality issues.
  • Communicates quality control information to all relevant organizational departments, outside vendors and contractors.
  • Investigates customer returns and complaints. Oversees development and implementation of corrective action measures to prevent re-occurrences.
  • Implements procedures to assure that products comply with customer specifications.
  • Coordinates, as needed, the administration of the defective material identification & disposition program; i.e., the PMDR & MRB program.
  • Monitors & takes corrective/improvement action on key quality measurables; i.e., parts per million (PPM), repeat complaints.
  • Performs or delegates the quality department functions defined in our APQP process.
  • Assures control plans and checking methods and tools therein, are meaningful and effective.
  • Provides training to manufacturing personnel to assist in the preparing definition and monitoring of quality requirements.
  • Monitors existing business practices to ensure compliance with existing policies and procedures (ISO compliance).
  • Serves as the quality management representative, representing the quality management system to external organizations.
  • Supports product development and transfer into production to ensure process capability exists and product requirements are understood.
  • Participates in conducting both internal and vendor audits; including 2nd and 3rd party quality system audits.
  • Supports purchasing in supplier performance measurement.
  • Oversees and directs activities of quality department staff in support and maintenance of quality systems.
  • Manages individual performance providing coaching, mentoring and performance feedback to ensure that plant objectives are achieved. Instructs and mentors quality staff in quality control and analytical procedures.
  • Generates and maintains quality operating budgets.
  • Develops and implements quality training programs to train employees on the appropriate and necessary quality systems, techniques and methods including ISO 13485 and statistical methods.
  • Produces reports regarding nonconformance of products or processes, daily production quality, root cause analyses and quality trends.
  • Manages internal/external calibration of all required measurement devices, gauges and testing equipment.
  • Fluent in statistical tools to conduct SPC, design of experiments, gage R and R and new product introduction control plans.
  • Supports new product introduction with design reviews, PFMEAs, and CTQs.
  • Assists other plants in assuring quality systems are in compliance, as required.

QUALIFICATION REQUIREMENTS

 

  • Bachelor's degree or equivalent in quality, operations management or engineering related field.
  • A minimum of 5 year’s experience in manufacturing with at least 2 years in a management and/or supervisory capacity.
  • Proven experience within a medical device manufacturing and governmental regulations and standards (21 CFR Part 820, ISO13485, MDR).
  • Certified Quality Engineer (CQE or ASQ) certificate/training a plus.
  • Demonstrated ability implementing “world-class” quality management practices to drive continuous improvement throughout the quality systems.

Other Job-Specific Requirements:

  • Bilingual in English / Spanish (Fluent).
  • Work Visa or Dual Citizenship
  • Excellent interpersonal and communication skills (both verbal and written).
  • Able to train and develop his/her Quality Team, and a strong Team Building partner.
  • Strong people management and development skills.
  • Strong listening skills.
Reference :
UFP
Contract :
Permanente
Job(s) available(s) :
1
Experience :
7~10 Años
Studies level :
Maestría / Otros
Working place :
TIJUANA
Creation date :
09/22/2021
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Co-Production International Mexico Manufacturing Service Provider

mexico icoMexico Corporate Office
Phone: +1855.480.0837 / +52(664)454-3330
Blvd. Corredor Tijuana-Rosarito 2000
15202 Int. Mt8, Zona Cerril General
Tijuana, BC 22330, Mexico
reclutamiento@co-production.net

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