Sr Continuous Improvement Quality Engineer CAPA Specialist
Sr Continuous Improvement Quality Engineer CAPA Specialist
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Job Description
Primary Function of Position:
Ensure that quality systems products and manufacturing processes comply with quality standards by supporting and driving improvements in the organization and in accordance with international industry practices and regulations (ISOCFR820; to meet the objectives provide support and expertise in corrective and preventive actions (CAPAs) process and system and implementing actions to drive the improvement. S/he will partner with subject matter experts on various corrective and preventive (CAPA) activities in addition to supporting other improvement initiatives. S/he will evolve existing processes/systems to ensure timely escalation identification of product quality and compliance issues within a closedloop quality management system.
Roles & Responsibilities:
- Support and comply with Company and Sites Health Safety and Environmental programs and requirements including:
- Use of personal protective equipment (PPE).
- Participates in the emergency brigades and/or Health and Safety Commission when required.
- Use devices accessories tools and equipment according to the process verifying that they are in good condition for use and reporting those that are in poor condition for repair.
- Communicates unsafe acts or conditions to their superiors.
- Participates in the Health Safety and Environment courses established.
- Maintains order and cleanliness in the workstation 5S) under responsibility.
- Report any condition and/or behavior that could represent a safety risk
- Complies with health regulatory and International Standard (ISO13485 requirements Company and site policies operating procedures processes and task assignments.
- Participate in or lead the completion of CAPA projects assuring compliance quality and timeliness of records.
- Communicate confidently and effectively with all levels of management peers and key stakeholders including timely escalation of quality issues.
- Collaborate with crossfunctional teams using various methodologies (e.g. Six Sigma root cause analysis/problemsolving skills).
- Independently investigate gather data trends and perform preliminary analysis.
- Process requests ensuring owners are assigned and timely responses and approvals are provided in alignment with quality goals.
- Leads meetings and communications for CAPA updates information and concerns.
- Responsible for assisting with metrics and reporting in accordance with established procedures.
- Support the team in delivering and overseeing the CAPA training program.
- Assist in initiating processing and completing CAPA records in the electronic system.
- Execute and provide ontime completion of Quality Engineering deliverables.
- Provide support and CAPAs process/system subject matter expertise during audits and inspections.
- Support the review and approval of any documentation required by CAPA deliverables.
- Mentor CAPA teams and colleagues who are beginnerlevel in CAPA processes and systems.
Qualifications :
Required Skills and Experience
- Bilingual (English / Based site language) Advanced
- Quality Engineer: Systems Assurance or Quality Control Minimum 5 Years experience
- Have worked in a regulated manufacturing industry: Medical devices Pharmaceuticals Aerospace Automobile Food etc. Minimum 5 Years
- Previous CAPA and/or engineering experience and demonstrated use of quality tools/methodologies. Minimum 5 Years of work experience
- Detailed knowledge of Quality System Regulations 21CFR820 and ISO 13485. Minimum 3 Years
- Ability to work in a highly matrixed and geographically diverse business environment
- Quality/Compliance focus and attention to detail
- Critical thinking skills for analyzing risk use of root cause analysis tools and technical aptitude to collect and analyze data for determining an improvement strategy
- Expertise in cGMP and CAPA documentation
- Computer skills (advanced Microsoft Office Package and statistical/data analysis and report writing skills)
- Strong verbal/written communication skills (communicating effectively at multiple organizational levels)
- Multitasks prioritizes. and meets deadlines in a timely manner
- Solid interpersonal organizational and followup skills
- Passionate about making products and processes better
- Demonstrated impactful project management and leadership skills including the ability to lead multidepartmental project teams and resolve qualityrelated issues in a timely and effective manner.
- Ability to work within a team and as an individual contributor in a fastpaced changing environment.
- Ability to leverage and/or engage others to accomplish projects.
Preferred Skills
- Knowledge of Process improvement tools and methodologies (Lean Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus
- CAPA Review and Approval
- Project Management experience working in a broader enterprise/crossdivision business unit model
Required Education and Training
- Engineering Bachelors degree Preferably in science or healthcare fields.
- ASQ certification: CQE CQA Preferred.
- Six Sigma and/or Lean certification or training Preferred
Additional Information :
Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados y prohibimos cualquier tipo de discriminacin y acoso independientemente de su raza sexo condicin de embarazo orientacin sexual identidad de gnero origen nacional color edad religin condicin de veterano protegido o de discapacidad informacin gentica o cualquier otra condicin protegida por las leyes federales estatales o locales aplicables.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
