Job Listing

JOB DESCRIPTION

Quality and Regulatory Management Manager (HOD)

Summary of Job Function

The QRM Manager of Quality and Regulatory Management (QRM) is responsible for the overall quality of products, processes and regulatory compliance for the Malaysian Operations. This individual must provide leadership for the QRM organization and for the overall Operations.  This leadership must be in accordance with both Divisional QRM initiatives and Malaysian Operations initiatives.  The QRM Manager will interface with Divisional and Business Unit executives in order to ensure consistency and communication within organization.  A focus on continuous improvement in all areas is imperative.  Areas included in the basic function of this position are:  Customer-driven toll manufacturing and sourcing initiatives, Quality Leadership Process initiatives, United States Food and Drug Administration Regulatory Compliance, EC Medical Device Directives Compliance, International regulatory compliance, customer complaint coordination, documentation practices, chemistry and microbiology laboratories activities, total integrated quality initiatives, Operational Excellence and LSS initiatives, and general plant operational support. The QRM Manager is also the Management Representative of the Malaysian Operations.

Know-how Requirements

To perform successfully in this position, the incumbent must have at a minimum a Bachelor’s degree in either life science, physical sciences or engineering.  An advanced degree is desirable. A comprehensive understanding of quality processes, manufacturing operations and control procedures within a manufacturing operation is required.  A minimum of 10 years of manufacturing or related industry experience is needed. 

Specific Responsibilities

1)  The incumbent’s principal challenges involve maintaining professional competence in a wide range of technical, scientific and regulatory fields while promoting excellent working relationships with a large number of senior managers.  The incumbent is expected to operate with a heavy reliance on personal experiences, knowledge and skills.  Relations with Government agencies, the industry and user groups require the exercising of discretionary judgement.

2)  The incumbent will provide hands-on technical expertise which require special assistance in resolving issues and identifying risks.  This may include recommendations as to appropriate actions and evaluations of resources required.

3)  Development of staff and overall organization is a vital aspect of this position.  Methodologies such as career development plans/actions, empowerment, diversity practices, team work, coaching and training must be utilized.

4)  This position will facilitate the exchange of best demonstrated practices through the participation with the Business Unit, Divisional and other personnel.  The incumbent must use a systematic approach to managing quality improvement and will be responsible for establishing specific quality measurements and direction.

5)  Product quality.

6)  In co-operation with other function, defines, implements and supervises the processes aimed at assessing and meeting Customer requirements.  The focus must be proactive, a prevention-based approach aimed at not creating defects.  The focus is to have capable and stable manufacturing systems.

7)  Responsibilities include management and subsequent corrective action in response to Customer dissatisfaction (customer complaints).

8)  As a member of the senior management team this position assists with compliance to the commitment to quality excellence.  The position serves as a key contributor for the development and implementation of strategic plans and ensures accurate reporting of performance against those plans.

9)  Ensures that the requirements of the quality systems are implemented and maintained throughout the operations.  Ensure the definition of such requirements are consistent with: Operational, Business Unit, Divisional, Corporate, United States Quality Systems & Regulatory Standards and Medical Device Directives.

10)  Reports significant quality and regulatory issues to Divisional QRM personnel and ensures good bilateral communications with other glove business unit personnel.

11)  Regulatory and Good Manufacturing Practices compliance. EC Medical Device Directive Compliance.  International regulatory compliance.

12)  Provide direction for activities to ensure that regulatory requirements are understood and are addressed in the product development and manufacturing activities. This includes direction and approvals for products and process changes.  Support marketing in all matters relating to quality assurance.

13)  Ensures the review of draft laws, regulations and standards for their potential impact on the glove business unit and prepares appropriate commentaries while co-operating with other glove business unit plants and functions.

14)  Manages the internal quality and regulatory assessment program.

15)  Manages the total supplier quality process.

16)  Provides direct support for plant evaluation and solving of issues which involves plant operations.  This is accomplished by providing technical, analytical and managerial skills.

17)  Direct supervision and development of the Quality and Regulatory Management functions at the Penang operations.  Through this responsibility, ensures that all operations are adequately staffed with QRM professionals.  Also ensures that training programs are in-place and the performance review/career development process result in continuous improvement.  Development of personnel to ensure advancement of their abilities and knowledge is also a vital aspect of this position.