דרושים Quality Technician ב-Boston Scientific ב-מלזיה

Job Respondsibilities:

• Work with Manufacturing Engineers in developing, trouble shooting, standardising and improving existing production methods and procedures.

• Work on Electronic troubleshooting, P.L.C. programming, electronic hardware interfacing.

• Take a lead role in investigating and implementing new production methods.

• Modify existing and develop new tooling and fixtures

• Revise existing documents, processes, and/or methods to correct or improve processes/product

• Work with vendors/suppliers to procure and install tooling, fixtures, and/or equipment

• Perform equipment qualifications and validations, including report writing etc.

• Design, specify, manufacture, test and document production equipment, changes and improvements.

• Take responsibility for creating and completing preventative maintenance procedures with an assigned process or area.

• Assists in implementing technical improvements under the teams C.I.P. program.

• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.

Job Requirements:

• Candidate required prosess at least Diploma in Engineering (Mechanical, Manufacturing, or related field).
• Minimum 7 years of experience manufacturing or equipment technician.
• Proven track record in product transfers, equipment qualification, and process validation.
• Experience in working within a matrix organization and cross-site collaboration.
• Prefer hands-on Manufacturing/Equipment Technician to support equipment setup.
• The ideal candidate has experience in troubleshooting, validation support, and production line readiness.
• Must be proactive, able to work in a fast-paced environment, and comfortable with hands-on tasks.

Purpose Statement:

The successful candidate will work under minimal supervision on the development of robust, capable, cost effective & safe manufacturing processes, equipment, materials and products and supports efficient and effective transfer of new products & processes into commercial production. This level position requires an extensive knowledge base and a high degree of independence.

Key Responsibilities:

• Demonstrates extensive technical expertise (SME) on product / process technologies to develop solution for design improvement, optimisation, validation and troubleshooting of those technologies.

• Collaborate through developed networks (both internal & external) in assisting engineering teams in the selection, design & development of new product, processes, equipment, tooling and materials.

• Develop / lead the execution of experimentation and testing to enable characterisation, optimization and troubleshooting of processes and equipment; summarises, analyses and draws conclusions leading to effective technical resolution & communication to wider technical community.

• Coordinates/directs the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.

• Lead / support continuous improvement activity – through effective application of Six Sigma & Lean methodologies to assist in the characterization, optimization, troubleshooting and development of efficient, cost effective equipment and processes.

• Supports execution and documentation of validation builds, co-ordinates testing of validation units and compiles, analyses and reports on the validation results.

• Travel to other sites / vendors as part of technology development & transfer activities.

• Train/Coach peers on the technical aspects of their job; Trains production trainers/operators/manufacturing technicians on new processes.

• Provides floor support for new product builds (e.g., troubleshoots equipment and manufacturing problems).

Requirements:

• Candidate must possess at least a Diploma/ Degree in Engineering, Science or equivalent.

• At least 5 years working experience in Manufacturing environment.

• Prefer candidate with Photonic/ fiber optic background.

• Required skill(s): Equipment Troubleshooting, Problem Solving
  Process Improvement, and Lean Six Sigma.

• Required language(s): Bahasa Malaysia, English.

• 2 full time positions available.

Key Responsibilities:

• Provide support to the validation department in regards to decisions on what systems require validation as well as support the validation/remediation of software installed in the company, maintain the change control of the software and provide guidance in IQ creation and execution.

• Identify areas that may require software validation and advice system owners about validation requirements.

• Analyze areas for improvement and recommend/advice about software solutions

• Maintain procedures related to Software Validation.

Job Requirements:

• Degree in Engineering / Science

• At least 2 years experience in Equipment installation qualification, software validation/ process validation

• Required skills: Basic statistical skills, Minitab, Problem solving

Key Responsibilities

• Work with Manufacturing Engineers in developing, trouble shooting, standardizing and improving existing production methods and procedures.

• Work on Electronic troubleshooting, PLC. programming, electronic hardware interfacing.

• Maintain a critical spares inventory for key maintenance items to minimise downtime.

• Assist ME’s in investigating and implementing new production methods.

• Assist ME’s in design methods, part sourcing and documentation.

• Perform equipment qualifications and validations, including report writing etc.

• Design, specify, manufacture, test and document production equipment, changes and improvements.

• Interface with a variety of BSIL personnel and with outside vendors when necessary while performing the above.

• Take responsibility for preventative maintenance procedures with an assigned process or area.

• Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.

Requirements :

• Candidate must possess at least Diploma in Engineering (Electrical/Electronic)/ Engineering (Mechanical)/ Engineering (Mechatronic/Electromechanical) or equivalent.

• Required skill(s): equipment maintenance, equipment qualification, manufacturing, critical thinking, Problem Solving.

• Required language(s): Bahasa Malaysia, English

• At least 5-8 year(s) of working experience in the related field is required for this position.

• Able to work on rotating shift schedule (3 shifts).

Key Responsibilities

• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
• Co-ordinate the work activities within the various work teams and ensuring that adequate resources are available; to meet customer expectations.
• Maintains and enhances cross-functional /site team relationships.
• Is an effective people manager resulting in a motivated high-performance team and is fully motivated to achieve and demonstrate best practices in line with the department and Strategic Quality Planning (SQP) objectives.
• Provides direction and support to subordinates based on general policies and management guidance.
• Responsible for performing performance appraisals, for all reporting staff.
• Co-ordination of staff holidays and for ensuring sufficient cover is available to support manufacturing during shut down periods.
• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in
• identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Participates in Customer Complaints investigation for areas under their control or Laboratory Out Of Specification (OOS) investigation.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decisions
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
• Is familiar with the internal auditing process.

Requirements

• Minimum Degree in Engineering or Science
• Minimum 10 years of experience in manufacturing / operations Quality. Prior experience in the medical device industry is preferred.
• Required skills: Good interpersonal, problem solving & communication skills. Process validation. Direct reports and people management, leadership.
• Experience in product transfer will be added advantage.

Key Responsibilities

• Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
• Co-ordinate the work activities within the various work teams and ensuring that adequate resources are available; to meet customer expectations.
• Maintains and enhances cross-functional /site team relationships.
• Is an effective people manager resulting in a motivated high-performance team and is fully motivated to achieve and demonstrate best practices in line with the department and Strategic Quality Planning (SQP) objectives.
• Provides direction and support to subordinates based on general policies and management guidance.
• Responsible for performing performance appraisals, for all reporting staff.
• Co-ordination of staff holidays and for ensuring sufficient cover is available to support manufacturing during shut down periods.
• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in
• identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
• Participates in Customer Complaints investigation for areas under their control or Laboratory Out Of Specification (OOS) investigation.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decisions
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
• Is familiar with the internal auditing process.

Requirements

• Minimum Degree in Engineering or Science
• Minimum 10 years of experience in manufacturing / operations Quality. Prior experience in the medical device industry is preferred.
• Required skills: Good interpersonal, problem solving & communication skills. Process validation. Direct reports and people management, leadership.
• Experience in product transfer will be added advantage.

Key Responsibilities

• Develops and manages a high-performance quality engineering team with a focus on customer needs, compliance, product quality, and risk mitigation.
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Assists in and/or manages functional deliverables and ensures technical excellence for product or technical development.
• Participates in Customer Complaints investigation for areas under their control.
• Is viewed as a leader or expert in the areas of QSR and ISO/MDD standards within one's own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Site QA Director as the final arbitrator on critical quality decisions.
• Develops, directs and executes plans for major segments of complex projects from a quality perspective.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality management system on-site and across the Corporation where possible.
• Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the department/site.
• Is an effective people manager resulting in a motivated high performance team. Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the department and quality objectives.
• Assists in and/or completes the development of budgets and monitors spending.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Is familiar with the internal auditing process.
• To establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area

Requirements

• Minimum Bachelor of Science in Biomedical Science or equivalent degree or Engineering Degree.
• Minimum 10 years of experience working in managerial capacity within a production environment in medical industry.
• Well versed in ISO 13485 and 21 CFR 820 requirements.
• Minimum 3 years of experience managing engineers and technicians.
• Required skills: People management skills, Problem solving skills, Risk Management skills, Excursion handling skills.
• Knowledge of statistics and understanding of Finance 101 will be added advantage.