Quality Operations Lead

hace 4 días

Ciudad Juárez, México Johnson & Johnson A tiempo completo

**Job Function**:Quality**Job Sub Function**:Quality Assurance**Job Category**:People Leader**All Job Posting Locations**:MX301 - Circuito Interior Norte - BWI, MX905 Manuel Talamas Camandari 2849, Lote Bravo, Ciudad Juarez, ChihuahuaFueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.**We are searching for the best talent for Quality Operations Lead to be in Juarez City.****You will be responsible for**:- Leads or support quality improvement initiatives, such as the characterization of processes and products that leads to continuous improvements / cost.- Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other tools and improvement programs.- Performs benchmarking in order to develop more effective methods to improve quality.- Establishes and formulates the quality metrics to maintain the quality assurance objectives and alignment with the objectives of the plant.- Supports the development of quality engineering and the compliance with the quality with the adequate abilities for the introduction of new products and product life cycle management.- Promotes and supports the implementation of quality, product and process improvement projects.- Revises and approves Engineering Change Orders (ECOs).- Evaluation, monitoring and analysis of the quality costs in order to maintain a quality system according to the medical industry standards- Revises / analyzes if the current products and processes (including performed actions or decisions) comply with the regulations, such as the QSRs, ISO 13485, etc.- Leads the preparations activities for regulatory agencies audits, including the active participation as “SME” or “Escort” (for example: FDA, JJRC, BSI, etc.).- Revises and approves the answers to internal and external audit observations ton ensure the compliance with the internal procedures and applicable regulations.- Directs and attends to Revision meetings of NCs as a member of MRB.- Revises and approves the investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints and escalation of quality problems when applies.- Provides direction and assigns resources for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level.**Qualifications / Requirements**:- As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable science.- Master or Doctorate in applicable sciences, preferable.- 8 to 10 years of work experience, or demonstrated performance- Use of computer packages.- Ability to effectively deal and negotiate with representatives of various governmental agencies and auditing agencies.- Excellent communication skills in English, spoken and written.- Ability to perform “active involvement” in the solution of problems and resolution of problems, preferably.- Capacity to solve problems providing good judgment is highly desired.- Certifications such as CQA, CQE, CQM (preferably), CBA, MBB or BB are a plus

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