Copy of Sr Continuous Improvement Quality Engineer (CAPA Specialist)

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

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., ISO 13485, 21CFR820).  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 closed-loop quality management system.

Essential Job Duties

• Support and comply with Company and Site’s 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 cross-functional teams using various methodologies (e.g., Six Sigma root cause analysis/problem-solving 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 on-time completion of Quality Engineering deliverables.
• Provide support and CAPA’s 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 beginner-level 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 multi-departmental project teams and resolve quality-related issues in a timely and effective manner
• Ability to work within a team and as an individual contributor in a fast-paced, 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
• Multi-tasks, prioritizes. and meets deadlines in a timely manner
• Strong interpersonal, organizational, and follow-up skills
• Passionate about making products and processes better

Required Education and Training

• Minimum education: Engineering Bachelor’s 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/cross-division 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 COVID-19.  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 market-competitive 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.