Process Engineer, Lamination

Quality Assurance Manager

Quality Engineer

Reliability Technician-Facilities

Senior Engineer, Firmware (Core)

Quality Engineer Auto Assembly

Quality Assurance Specialist/Engineer

Responsibilities: <ul><li>Responsible for backend semiconductor packaging processes which involve autoclave, wet-benches, moulding and curing oven process.</li><li>Initiate process evaluation, implementing and driving process</li><li>Drive improvement projects (including yield improvement, productivity and cost reduction projects).</li><li>Troubleshoot and resolve process-related issues and support equipment manufacturing activities as well.</li><li>Define, document and maintain process requirements, specifications and work procedures.</li></ul> Requirements: <ul><li>Bachelors Degree of Engineering (Mechanical / Material / Chemical)</li><li>Experience in the semiconductor backend assembly process is an advantage, especially in an autoclave, wet-benches, moulding and curing oven process.</li><li>Familiar with SPC, process control, FMEA and DOE.</li></ul>

Responsibilities:&nbsp; <ul><li>You will lead the Quality department assuring full compliance of manufactured products (combustible cigarettes, smoke-free products, etc.) with the established requirement of the Quality Management System (QMS) and tolling where applicable.</li><li>You will support innovation in the organization by ensuring quality systems are followed and continually improved and deliver competent support to all relevant departments and/or other production center in order to design</li><li>Achieve and develop highest quality standards in each process, while building and sharing knowledge across.</li><li>You will also ensure compliance of the organization to relevant quality standards and ensure a constant state of inspection readiness with respect to all relevant regulations and guidelines.</li></ul> Requirements: <ul><li>At least 5 years of experience in Quality Assurance within the tobacco, food, pharmaceutical or similar industry</li><li>At least 2 years of experience as people manager. Good collaboration and stakeholder management as well as a working knowledge of Microsoft Office Tools such as Word, Excel and Powerpoint is also required.</li><li>You must also be amenable to work in Batangas Plant</li></ul>

Purpose of the Job: <ul><li>This is a high visibility position that requires extensive change management with responsibilities for the quality and consistency of the company’s products.</li></ul> Responsibilities: <ul><li>Support new product launches as required, including PFMEA, capability studies, control plans, design review, gauging, etc.</li><li>Review Engineering Change Notices, track the status of QA activities and support implementation of engineering changes.</li><li>Drive internal and external corrective and preventative action.</li><li>Lead multi-functional teams to analyze nonconforming conditions and determine root cause.</li><li>Develop engineering change request in response to production and warranty issues.</li><li>Support the set-up and maintenance of quality procedures.</li></ul> Requirements: Experience &amp; Education: <ul><li>Bachelor’s Degree Required, Engineering discipline preferred – with a minimum of 2 years’ experience in the field of Quality.</li><li>Will consider Technical/Science/Industrial Management majors with minimum 5 years of Quality specific experience.</li><li>Six Sigma certification preferred.</li><li>ASQ certification (CQE, CQA, and CQM) preferred.</li><li>MBA/Graduate Degree a plus.</li><li>ISO experience a plus.</li></ul>&nbsp;Key Competencies: <ul><li>Strong analytical, quantitative, and problem solving skills.</li><li>Fully familiar with FMEA, Control Plans, SPC</li><li>Problem solving utilizing six-sigma tools &amp; principles; strong corrective action skills.</li><li>Flexible – ability to adapt to frequent priority changes &amp; substantial role diversity.</li><li>Ability to lead teams or direct reports.</li><li>Multi-task oriented; highly motivated; self-starter.</li><li>This person should have exceptional interpersonal and teambuilding skills. Also important are excellent presentation skills to both shop floor personnel and executive management. Excellent written communication skills, including process documentation.</li><li>Project management, follow-up, and team skills essential.</li><li>This person must have the motivation, talent, and ability to fill higher level roles&nbsp;</li></ul>

Responsibilities: <ul><li>Completes a variety of assignments independently based on established procedures.</li><li>Identifies maintenance improvements that drive increased efficiency, throughput and quality. Ability to provide training.</li><li>Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options.</li><li>Troubleshoots equipment issues and, as a team member, analyzes root causes and makes recommendations.</li><li>Exhibits teamwork and motivates others to achieve project objectives.</li><li>Collaborates within own work unit and with those from other departments outside of work unit and/or with external vendors/suppliers.</li><li>Limited supervision required on routine work and general instructions given on special projects or new assignments.</li></ul> Requirements: <ul><li>Diploma or equivalent with 7 years’ related experience &amp; certification in assigned area, as required ACCP-Level II (Non-Destruct) Certification or equivalent experience.</li><li>Troubleshoots all relevant equipment independently.</li><li>On-the-Job Training of Maintenance Technicians.</li><li>Supports engineering and capital projects with input on equipment acquisition or repair.</li><li>Fully knowledgeable of cGMP regulations and processes.</li><li>Qualified and demonstrated competence in equipment maintenance, repair &amp; set up.</li><li>Interfaces with external vendors &amp; service providers.</li><li>Has thorough knowledge and skills needed for the position.&nbsp;</li><li>Has a wide range of technical skills and operational knowledge.</li><li>Understands the practical applications to problems and situations ordinarily encountered.</li></ul> Proficient in following areas: <ul><li>Ability to assess and perform PM tasks.</li><li>Ability to read schematics, technical drawings and blueprints</li><li>Proficient in all equipment in manufacturing area.</li><li>Understanding of Non-destruct Test Methods &amp; P-F curves and FMEA Proficient in trouble shooting &amp; repair in 4 or more of the following areas:</li><li>Electrical, Hydraulic, Pneumatics, Mechanical, PLC.</li></ul>

Responsibilities: <ul><li>Lead devices firmware (FW) development aspects and prototyping of core electronics new technology. </li><li>You will also provide technical risk assessment and make EVT and FMEA for the FW part of core electronics module.&nbsp;</li><li>Handle firmware roadmap development for critical electronics components and modules and support processes and tools improvements dedicated to development of core technology for RRP devices.</li><li>Ensure a detailed communication of the new FW modules introduction plan with all partners (Product and Process Technology, Product Development team, Design Validation team, external Development partners) and record all needs for new features and product improvements by crafting a suitable FW release plan.</li><li>Coordinate firmware development aspects and prototyping to meet the agreed product functional requirements and international certifications if applicable. </li><li>Create a roadmap of firmware modules able to speed-up the prototyping phase.</li><li>Lead the Firmware modules development plan and the Firmware part of the POC of new technology.</li><li>Provide technical expertise on firmware development to support device architects and PPT team.</li><li>Supervise development of critical firmware modules covering the different core technology for RRP devices platforms in collaboration with the different partners.</li><li>Manage detailed FW design of core electronics engineering in collaboration with internal and external partners (PPT, ePDC, Device architects, ME eng, EE eng).</li><li>Follow-up each FW release project, control the budget, schedule and performance, advise collaborators in case of deviation.</li><li>Improve processes and tools which support the development of core electronics firmware.</li></ul> Requirements: <ul><li>University degree in SW Engineering (Bachelors or Masters or PhD level) or equivalent.</li><li>Meaningful product related FW design experience. </li><li>Relevant Industries would be:- consumer/mobile electronics - automotive electronics - Electronics Manufacturing Services (EMS) - medical device manufacturers - scientific instrument manufacturers - automation product/service providers.</li><li>Experience (or awareness) in medical device and process development would be desirable.</li><li>Direct experience in SW and FW development, ideally C programming language and technical project management.</li><li>Ability to build effective partnerships with external companies to extend FW capabilities.</li><li>Experimental approach mindset, oriented to quality of results with technical decisions taken on the basis of objective data and proven track record in problem solving.</li><li>Ability to work in an autonomous way and communicate effectively, both verbally and in writing, with various partners.</li><li>Proficiency in English (both written and oral).</li></ul>

Responsibilities: Customer Quality: <ul><li>Analyze product failure to define corrective and preventive action to respond to customer complaints.</li><li>Communicate with customer in timely manner in regard to data summary, customer updates and corrective action reports.</li><li>Coordinate with Quality Personnel and other departments and personnel to discuss and resolve product quality issues raised by customers.</li><li>Participate in product quality planning and control processes based on customers specifications and requirements that are initiated by customer quality issues.</li><li>Inform quality management team regarding customer feedback and expectations on products quality.</li><li>Prepare and update all necessary quality reports and procedure as required by customers and procedures.</li><li>Train and guide quality team in identifying and developing problem solving methodologies to resolve customer quality issues.</li><li>Prepared 8D report to customer which include root cause analysis and corrective action on time.</li><li>Perform 8D corrective action that written in 8D report to ensure that corrective action that committed is close and implemented.</li></ul> Auto Assembly MQA: <ul><li>Streamline for part measurement by removing stable dimension and move from part measurement to part application by reviewing all inspection standard.</li><li>Review and develop suitable / effective inspection gate in auto assembly to enhance on detection and prevent leak out.</li><li>Responsible in ensuring the quality auto assembly part and resolving quality issue encountered at production.</li><li>Performing process line audit to access on product / process quality.</li><li>Drive for QN and RN improvement.</li><li>Drive for QAP reduction and involve in stop sorting activity.</li><li>Leading in quality and productivity improvement activities both at manufacturing plants and supplier.</li><li>Drive for subcon for quality improvement</li><li>Drive for CTP / CTQ dimension improvement at subcon to reduce Auto Assembly QAP.</li><li>Benchmark good practice / control at subcon to implement in auto assembly</li><li>Share good practice / control that implement in auto assembly to subcon.</li></ul> Requirements: <ul><li>Degree in a Science or Engineering discipline</li><li>Manufacturing Quality Engineer</li><li>Minimum 2 years as a Quality Engineer.</li><li>Ability to perform engineering analyses &amp; drive to root cause of processing problems.&nbsp;</li><li>High degree of organizational skills as juggling multiple projects and managing them to specific timelines is expected.&nbsp;</li><li>Basic computer skills including work processing &amp; spreadsheets.&nbsp;&nbsp;</li><li>Able to communicate effectively both in writing, one on one verbal, and group meetings.&nbsp;</li><li>Good interpersonal skills sufficient to provide guidance to less experienced engineers.</li><li>Knowledge of statistical tools and SPC.</li><li>Basic analytical skill.</li><li>Understand FMEA and control plan.</li><li>Basic auditing skills.</li><li>Preferred : Familiarity with database development, SPC software, and design of experiments and Six Sigma Green Belt or Black Belt certification</li><li>Location – Perai Penang&nbsp;</li></ul>

Job Role: <ul><li>The Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical and pharmaceutical industry.&nbsp;</li><li>Our products are used, among other things, in the production of medical devices and controlled release medicines.&nbsp;</li><li>The products are developed and produced to customer specifications in our factories in Gorinchem, The Netherlands and Tucker, GA, USA.&nbsp;</li><li>This requires very intensive contact with the customer. The application area and the specific market require a very high level of quality and service.</li><li>The Biomaterials Quality Assurance department ensures that raw materials, production process, packaging, storage, transport and service continuously meet and exceed these high standards.&nbsp;</li><li>This makes sure that our customers receive the consistent high quality product from our client that they have become accustomed to.</li></ul> Responsibilities: <ul><li>The Quality Engineer is responsible for ensuring procedures, systems and processes effectively meet the Quality and Regulatory requirements and Biomaterials business needs.&nbsp;</li><li>The successful candidate will be a seasoned professional with experience in pharma, medical device or related FDA regulated industry.&nbsp;</li><li>The individual should have a thorough working knowledge of ISO 9001; ICH Q7; CFR 210/211; CFR 820; ISO 13485 and other applicable regulations.&nbsp;</li><li>As Quality Engineer you will be the quality lead in Strategic projects involving introduction of new production processes and/or introduction of new products.</li><li>Support in maintaining and continuously improving the Quality Management System in compliance with GMP regulations and ISO requirements.</li><li>Provide compliance and quality guidance and training to the Operations, Research and Development and Quality Control departments.</li><li>Interact with internal stakeholders and internal/external customers to ensure Quality and Regulatory requirements for Strategic projects are identified and addressed as part of the project plan.</li><li>Drive the establishment of a proper quality control strategy for new processes and new products by applying quality risk management principles throughout the different phases of Strategic projects.</li><li>Coordinate Quality and Regulatory Affairs relating to Drug Master Files (DMF) and Device Master Files (MAF) ensuring filings meet requirements of Regulatory Agencies and business needs.&nbsp;</li><li>Support Commissioning, Qualification and Validation activities including associated documentation for new equipment.</li><li>Improve quality risk management procedures to ensure periodic review and performance reporting.</li><li>Maintain current knowledge of FDA, EMA and other international regulations, guidelines, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations and translate these to the Biomaterials business.</li><li>Perform annual product reviews for commercial products.</li><li>Support the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, Non-Conformance and Complaint handling.</li></ul>&nbsp;Requirements: <ul><li>Bachelor’s or Masters degree in Chemistry, Engineering, Life Sciences or other relevant area.</li><li>Minimum 2 years of experience as a Quality Engineer in pharmaceutical, medical device or other related industries.</li><li>Experience in maintaining Regulatory filings current and responding to requests from Regulatory Authorities.</li><li>Experience with Commissioning, Qualification and Validation activities for new production equipment.</li><li>Experience in applying Quality Risk Management principles and tools (ICH Q9, HACCP, FMEA, HAZOP, etc.).</li><li>Working knowledge of ISO 9001, ICH Q7, FDA CFR 210/211, CFR 820, ISO 13485 and other applicable regulations.</li><li>Strong written and verbal communication skills, in English and preferably in Dutch.</li><li>Some exposure to customer audits and/or regulatory agency inspections (e.g. FDA, notified bodies, etc.).</li><li>Proven ability to work cross-functionally to achieve business outcomes.</li><li>Attention to detail, commitment to quality, accuracy, efficiency, and consistency.</li><li>Ability to travel occasionally as determined by business requirements.</li></ul>

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7 fmea Jobs found

Process Engineer, Lamination

Quality Assurance Manager

Quality Engineer

Reliability Technician-Facilities

Senior Engineer, Firmware (Core)

Quality Engineer Auto Assembly

Quality Assurance Specialist/Engineer

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7 fmea Jobs found

Process Engineer, Lamination

Quality Assurance Manager

Quality Engineer

Reliability Technician-Facilities

Senior Engineer, Firmware (Core)

Quality Engineer Auto Assembly

Quality Assurance Specialist/Engineer

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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