Sr Continuous Improvement Quality Engineer CAPA Specialist
Sr Continuous Improvement Quality Engineer CAPA Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of the 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 (e.g. ISOCFR820). Meet objectives provide support and expertise in corrective and preventive action (CAPA) process and system and implementing actions to drive the improvement. S/he will partner with subject matter experts on various CAPA activities in addition to supporting other improvement initiatives. S/he will evolve existing processes/systems to ensure timely escalation identification and robust investigation of product quality and compliance issues within a closedloop quality management system.
Essential Job Duties
- Support and comply with Company and Sites Health Safety and Environmental programs and requirements including:
- Use of personal protective equipment (PPE) as applicable.
- 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.
- Complies with health regulatory and International Standard (ISO13485) requirements Company and site policies operating procedures processes and task assignments.
- Participate in and lead 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.
- Lead and 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 subject matter experts and action item owners are assigned and provide timely responses 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
- 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)
- 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
- Strong verbal/written communication skills with ability to communicate effectively at multiple organizational levels
- Multitasks prioritizes. and meets deadlines in a timely manner
- Strong interpersonal organizational and followup skills
- Passionate about making products and processes better
Required Education and Training
- Minimum education: Engineering Bachelors degree Preferably in science or healthcare fields.
Working Conditions
- Desk and meeting rooms
Preferred Skills and Experience
- ASQ certification : CQE CQA
- 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
- Experience working in a broader enterprise/crossdivision business unit model
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
EEO and AA Policy
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
