Leader, Quality Engineering
hace 4 semanas
Position**Sector / Department**- Leader, Quality Engineering- Quality**Job Position Accountabilities / Expectations**- Collaborate with compliance with applicable regulations and standards to ensure medical devices are safe and effective.- Coordinate all Quality Engineering resources in activities related to New Product Introduction or Product Line Expansion.- Coordinate and provide data, reports and trends for the launch of the finished product including functionality testing (before and after).- Carry out and/or review risk assessment for product implementation, processes and/or testing method through change control.- Ensure that all plant validation activity complies with current global SOPs and quality records are safeguarded.- It carries out statistical analyses for the development and implementation of sampling plans, in-process inspection and testing procedures.- Coordinate the process of investigation and response to Customer Complaints.- Coordinate at plant level, customer complaint activities related to the process.- To assist the Quality Assurance Manager in the planning, organization of the activities and work that are carried out in the quality department, such as the systems implemented and maintaining the standards according to the FDA and ISO 13485.- Manage and Review "Device Master Records".- Support the development of any qualification (IQ, OQ, PQ, SV, TMV, etc.) in a validation outside of quality processes. In the case of quality processes, lead the activity.- Assist to Sales Representatives in the explanation of the use of the product, risk assessments, trends and promote solutions when there is a quality situation with a customer.- Develops and implements in-process monitoring programs for quality and manufacturing operations. Collects and analyzes data to make data driven recommendations and/or decisions.- Lead and diligently partner with the project teams to facilitate the integration of the applicable quality system elements in every day work flow.- Provide and facilitate productive and useful technical reviews during various cross-functional design review.- Provides leadership that ensures quality engineering and projects initiatives are aligned with the business needs. Lead high performance team and drive performance results working with core teams and manufacturing partners to ensure strong design quality practices are applied.**Qualifications / Education / Experience / Skills Required**- Bachelor’s degree in engineering- Minimum of **5 years **Quality Engineering experience in a Medical Device and working knowledge of 21 CFR Part 820 & ISO 13485.- Working knowledge of the intended use of the product, manufacturing process, validations and risk management.- Working knowledge of Statistical Analysis Tools (such as, Minitab, SPC, JMP) and quality engineering tools (such as, Six Sigma concepts).- Leadership ability in using problem solving investigational technical tools, such as, Cause and Effect Analysis Diagrams, Process Optimization, Trend and Capability Analysis, and various Control Charts.- Excellent written and verbal communication skill and the capability to work and communicate in a cross-cultural environment.- Strong organizational, interpersonal and influencing skills and the ability to coordinate multiple projects.- English - Advanced level
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Leader, Quality Engineering
hace 3 semanas
Tijuana, México Avanos A tiempo completoPosition**Sector / Department**- Leader, Quality Engineering- Quality**Job Position Accountabilities / Expectations**- Collaborate with compliance with applicable regulations and standards to ensure medical devices are safe and effective.- Coordinate all Quality Engineering resources in activities related to New Product Introduction or Product Line...
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Quality Engineering Manager
hace 1 día
Tijuana, México Benchmark Electronics Tijuana, S. de R.L. de C.V. A tiempo completoResponsibilities Quality engineering staff amamagement Lead and drive Quality improvement in all areas Provide Support and coaching for QE staff in problem solvings Drive QE standardization methods all across CFT's Be main leader for Quality criteria discrepancies Coaching and mentoring to all QE and Inspectors staff Abnormal material management Generate...
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Quality Engineering Manager
hace 21 horas
Tijuana, México Benchmark Electronics Tijuana, S. de R.L. de C.V. A tiempo completoResponsibilities Quality engineering staff amamagement Lead and drive Quality improvement in all areas Provide Support and coaching for QE staff in problem solvings Drive QE standardization methods all across CFT's Be main leader for Quality criteria discrepancies Coaching and mentoring to all QE and Inspectors staff Abnormal material management Generate...
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Quality Engineering Manager
hace 2 semanas
Tijuana, México Barbachano International, Inc. A tiempo completo**THE COMPANY**Our client is a growing company based in California that has over twenty-five years’ experience specializing in the design and manufacture of high-quality RF & Microwave ceramic chip capacitors, inductors and integrated passives. Our client is a global leader in the production of high frequency ceramic solutions through optimization of...
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Quality Engineering Manager
hace 6 días
Tijuana, B.C., México Protective Industrial Products A tiempo completoJOB TITLEQuality Engineering ManagerDEPARTMENTQualityLOCATIONTijuana, MexicoCOMPANY SUMMARYPIP Global Safety is a leading global supplier and manufacturer of personal protective equipment (PPE), trusted by workers and safety professionals across industries and continents. With a 40-year legacy of innovation, quality, and responsiveness, we deliver...
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Director of Quality
hace 1 día
Tijuana, México Hillrom A tiempo completo**Director of Quality (QMR, Site Quality Leader Medical Device Manufacturing)** **-** ** ****Description**Currently we seek a Site Quality Leader and Director of Quality for the Tijuana manufacturing facility. S/he is the designated Quality Management Representative (QMR) for all aspects of Quality System implementation within that facility. This role...
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Director of Quality
hace 1 día
Tijuana, México Hillrom A tiempo completo**Director of Quality (QMR, Site Quality Leader Medical Device Manufacturing)** **-** **22122566** **Description** Currently we seek a Site Quality Leader and Director of Quality for the Tijuana manufacturing facility. S/he is the designated Quality Management Representative (QMR) for all aspects of Quality System implementation within that facility. This...
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Manager, Quality Engineering
hace 2 semanas
Tijuana, México Benchmark Electronics, Inc A tiempo completoBenchmark provides comprehensive solutions across the entire product lifecycle, leading through its innovative technology and engineering design services, leveraging its optimized global supply chain, and delivering world‑class manufacturing services. The industries we serve include: commercial aerospace, defense, advanced computing, next‑generation...
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Manager, Quality Engineering
hace 2 semanas
Tijuana, México Benchmark Electronics, Inc A tiempo completoBenchmark provides comprehensive solutions across the entire product lifecycle, leading through its innovative technology and engineering design services, leveraging its optimized global supply chain, and delivering world‑class manufacturing services. The industries we serve include: commercial aerospace, defense, advanced computing, next‑generation...
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Manager, Quality Engineering
hace 3 semanas
Tijuana, México Benchmark Electronics, Inc A tiempo completoBenchmark provides comprehensive solutions across the entire product lifecycle, leading through its innovative technology and engineering design services, leveraging its optimized global supply chain, and delivering world-class manufacturing services. The industries we serve include: commercial aerospace, defense, advanced computing, next generation...
