Technical Manager

Teleflex; Kamunting; On-site; MYR 120,000 - 180,000; Full time

Job summary

A global medical technology company seeks a seasoned program manager to oversee projects that enhance patient care. This role requires at least 10 years in manufacturing or engineering environments alongside a bachelor's degree in a technical field. Responsibilities include managing program plans, ensuring compliance with quality standards, and conducting risk assessments. Candidates should have strong project management skills and a proactive approach to problem-solving. Promoting a culture of customer-centric service is vital.

Benefits

Health benefits

Retirement plan

Work-life balance initiatives

Qualifications

• Minimum education bachelor’s degree in a technical field (Engineering or Science).
• At least 10 years’ experience in manufacturing/engineering environment.

Responsibilities

• Manage program plan including scope, schedule, cost, and risk management.
• Ensure the program conforms to the Quality System Regulation and other relevant standards.
• Develop detailed Process Maps and Transfer Validation Plans.

Skills

Project management

Risk management

Technical assessment

Statistical Process Control

Education

Bachelor's degree in Engineering or Science

Tools

Project scheduling tools

Validation protocols

Job description

Expected Travel: Up to 25%

Requisition ID: 12793

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose‑driven innovation, and world‑class products can shape the future direction of healthcare.

Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Global Operations

Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Principal Responsibilities

Principal Responsibilities

• Successful completion of the Program on schedule and on Budget.
• Management of the program plan including scope, schedule, cost, technical, resource and risk management.
• Establish and maintain detailed technical plans, estimates and schedules.
• Program tracking and reporting (cost, schedule, and milestone accomplishments), using Project scheduling, reporting and financial management tools as appropriate.
• Ensure the following deliverables are achieved as per the Teleflex procedure TG-000080
• Identifying any risks and develops mitigation plans, and communicating these to the Program Director.
• To ensure the implementation and maintenance, within the department, of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
• Ensure Program conforms to the Quality System Regulation (QSR), CMDCAS, MDD93/42/EEC, MDR, ISO 13485 and other relevant Standards.
• Lean out the manufacturing process for all products involved in the program
• All technical aspects (equipment, facility, etc.) of the project and to ensure that the products are analysed against all appropriate standards utilizing appropriate techniques and documentation.

(Sterility Assurance involvement is required during design/development phase for new controlled environment or cleanroom built to accommodate the transfer.)

Additional Program Responsibilities

• Manage all equipment which requires calibration are carried out and maintained
• Developing detailed Process Map for the processes, identifying key performance criteria, quality attributes and equipment, etc.
• Creating a Transfer Validation Plan (TVP) that defines the validation work statement for the transfer.
• Update the Sending and Receiving Site Validation Master Plans to reflect transfer activities.
• The review of the condition and capability of the manufacturing processes to produce to key product specifications, equipment, fixtures, and test equipment needed for the successful manufacture of the product.
• Technical assessment and screening of the product and or process is to be verified (either directly or indirectly) against the current manufactured product and/or Product Performance Specifications or equivalent technical documentation (i.e., DHF, DMR).
• Conduct engineering studies for key product outputs.
• Establish process input to output relationships prior to move and validation if identified by the teams.
• In cases where Statistical Process Control (SPC) is not deployed, it may be prudent to collect SPC data to facilitate the receiving site’s Quality Control Plan. This is not mandatory but is suggested for those critical processes not under SPC.
• Identification of special processes that will require validation or verification.
• Reviewing, revising, or generating the necessary documentation on equipment, tooling, specification, drawings, etc.
• Working with Quality on the validation of equipment, processes.
• Review Process Failure Mode Effect Analysis (PFMEA) and update if the review requires changes.
• Work with Technical Engineer, Process Engineers and Quality Engineer in executing the Validation protocols for facility validation, equipment validations, operation qualification validation and process qualification validations
• Ensure that in-process inspection and testing equipment’s are in place and meets the testing requirements
• Review all history for customer complaint, non-conformance such as NCR, SCAR, CAPA, Recall, EIF of all products involved in the program.

Qualifications

Education / Experience Requirements

• Minimum education bachelor’s degree in a technical field (Engineering or Science).

Experience

• At least 10 years’ experience in manufacturing / engineering environment.

Specialized Skills / Other Requirements

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities may evolve and change over time.

Equal Opportunity

Teleflex is an equal opportunities employer.

Teleflex, the Teleflex logo, Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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