CAPA Leader

GE HealthCare (United States); Lombardia; Presencial; EUR 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

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Resumo da oferta

GE HealthCare in Lombardy seeks a CAPA Leader to drive closure of CAPA/Deviation/Change Control records across sites, leveraging project management, Lean, and structured problem solving to ensure timely, compliant QMS outcomes. You will partner with Quality, Supply Chain, Operations, Engineering and Regulatory Affairs to protect patient safety and improve product quality.

You will represent GE HealthCare during audits and interface with regulatory authorities, coaching teams and leading CAPA

Qualificações

• Bachelor's degree in a relevant field.
• Significant Quality, Manufacturing or Engineering experience in a regulated industry (Medical Devices or Pharmaceuticals).
• Experience with CAPA, Deviation, and Change Control processes and GMP QMS.

Responsabilidades

• Ensures all areas of the QMS are analyzed and evaluated for input to the QMS record and regulatory requirements are met.
• Manages execution of the QMS records using project management, problem solving, and lean methodologies to ensure timely, robust decisions.
• Leads CAPA Review Boards and partners with site leadership to address risks.
• Owns site trending and data analysis for CAPA/Deviation/Change Control inputs.
• Leads others to develop solutions using statistical and analysis techniques.
• Ensures site audit readiness and supports external audits and interfaces with regulatory authorities.

Conhecimentos

CAPA / QMS Leadership

Cross-functional collaboration

Lean methodologies

Problem solving & root cause

Formação académica

Bachelor's degree

Ferramentas

TWD system

Descrição da oferta de emprego

Job Description Summary

In this role, the CAPA Leader will lead the effective closure of all CAPA/Deviation/Change Control records within specific sites/ departments across the PDx network. The CAPA Leader will drive timely, high-quality QMS record outcomes through strong project management, Lean methodologies, structured problem solving, and cross-functional collaboration.

As a key member of the Quality organisation, they will partner with stakeholders within Quality as well as Supply Chain, Operations, Engineering and Regulatory Affairs, to apply problem solving tools to protect patient safety, strengthen quality systems, improve product quality, and ensure regulatory compliance.

They will represent GE HealthCare during internal and external audits and may interface with regulatory authorities.

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

• Ensures all areas of the QMS are analyzed and evaluated for input to the QMS record, problems are escalated and documented appropriately, and regulatory requirements are met.
• Manages execution of the QMS records, employing project management, problem solving, and lean methodologies to ensure robust quality decisions and timeliness.
• Leads CAPA Review Boards, partnering with site leadership to proactively address risks.
• Owns site trending and data analysis for inputs to the CAPA/Deviation/Change Control process.
• Leads others to find creative solutions to address complex problems using a variety of statistical and analysis techniques.
• Ensures site audit readiness and supports Quality System audits, representing GE HealthCare to external agencies.
• Coaches and develops others in their organization as an individual contributor.

Qualifications

• Bachelor's degree from an accredited university or college
• Significant Quality, Manufacturing or Engineering experience in a regulated industry, either Medical Devices or Pharmaceuticals

Desired Skills

• Experienced user of the TWD system and the QA procedures governing Quality Events
• Established project management skills and Lean expertise. Ability to lead cross-functional teams to plan and execute projects on time.
• Demonstrated understanding of a GMP QMS and regulatory requirements
• Exceptional analytical, problem solving & root-cause analysis skills
• Ability to effectively manage execution of tasks with competing priorities.
• Excellent communication skills – presentation, verbal and written to all organizational levels.
• Demonstrated collaboration and conflict resolution skills. Experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions.
• Experience leading and implementing change
• Strong interpersonal and leadership skills.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Additional Information

Relocation Assistance Provided: No