Epicareer Might not Working Properly
Learn More

QA Director

Salary undisclosed

Apply on


Original
Simplified
  • 1. Global Visibility |2. Opportunity to be part of company expansion


About Our Client

This company is a leading electronics manufacturer, specializing in producing high-quality medical devices and instruments. The company is undergoing an expansion at the moment and are looking for talented individuals to join the team.

Job Description

  • Lead the Quality Team in developing continual quality improvements and ensure implementation and effectiveness of quality system are fulfilling the applicable quality and regulatory and customer requirements
  • Assures quality products and processes by establishing and enforcing quality standards and testing materials and products.
  • Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
  • Develops raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, and devising testing methods and procedures.
  • Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures according to applicable regulations and customer requirements
  • Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures according to applicable regulations and customer requirements
  • Institutes rework standards by devising inspection and physical testing methods and procedures.
  • Creates product quality documentation system by writing and updating quality assurance procedures according to applicable regulations and customer requirements
  • Maintains product quality and compliance by enforcing quality assurance policies and procedures and government requirements according to applicable standards and regulations. Interfaces with local and government regulatory authorities as required.
  • Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
  • Completes quality assurance operational requirements by scheduling and assigning employees and following up on work results.


The Successful Applicant

  • Education: Diploma, Degree, or Master's in a related field, preferably in Sciences.
  • Requires in depth knowledge of quality system standards such as ISO 13485, ISO 9001, FDA 21 CFR820. Requires experience managing audits from regulators and customer/supplier audits.
  • Strategic thinker and resulted driven
  • Strong experience in continuous improvement and capable of driving needed change.
  • Strong business development experience with strong background in medical product and manufacturing processes is required.
  • Experience with quality standards, ISO9001, ISO13485, TL9000, TS16949
  • At least 8 years of experience in a leadership roles and leading Engineering/Product Development teams.


What's on Offer

Attractive Monthly Salary

Contact: Joanna Darmarajah

Quote job ref: JN-092024-6538488