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- 1. Global Visibility |2. Opportunity to be part of company expansion
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.
- 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.
Attractive Monthly Salary
Contact: Joanna Darmarajah
Quote job ref: JN-092024-6538488
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