Program Manager, CAPA, Florence Site

6 days ago

Florence, South Carolina, United States GE Healthcare Full time

Job Summary

As a Program Manager, CAPA, Florence Site, you will be responsible for developing and maintaining systems, rules, and processes to ensure fulfillment of internal and external requirements. You will ensure that projects and products are capable and will meet specified standards (Preventive). You will have knowledge of best practices and how your area integrates with others; you will be aware of the competition and the factors that differentiate them in the market

Key Responsibilities

• Creates a Quality culture by driving compliance activities, supporting the total quality management system, and site trending to achieve Quality objectives.

• Facilitates the CAPA input processes of Nonconformance, Investigations & Concessions / Deviations.

• Leads execution of the CAPA system employing project management, lean methodologies, problem solving, and works cross functionally to ensure robust quality decisions and CAPA timeliness.

• Facilitates Product Holds when deemed necessary from CAPA, Nonconformances or Investigations.

• Leads others to find creative solutions to address complex problems.

• Ensures site audit readiness and hosts the Quality System audits, representing GE HealthCare to external agencies

• Leads the internal audit program, ensuring compliance with the GEHC QMS, all applicable regulations and standards, with escalation to CAPA as applicable.

• Supports achievement of site Quality objectives and QMS systems

Requirements

• Bachelor's Degree with a minimum of 5 years work experience, High School Diploma with 10 years of relevant work experience or Masters Degree with 3 years of work experience.

• Minimum of 5 years working in a regulated industry.

• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including, but not limited to FDA CFR 21 820 and ISO 13485.

• Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally)

• Ability to communicate effectively in English (both written and oral).

Preferred Qualifications

• Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry, or experience in design engineering or manufacturing engineering in the medical device field.

• Demonstrated knowledge of Quality Management System tools & continuous improvement methodologies

• Proven ability to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

• Experience performing internal and external audits.

• Demonstrated ability to make risk-based decisions in a compliant manner.

About GE Healthcare

GE Healthcare offers a great work environment, professional development, challenging careers, and competitive compensation. GE Healthcare is an Equal Opportunity Employer. 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.

GE Healthcare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE Healthcare does not currently require U.S. employees to be vaccinated against COVID-19, some GE Healthcare customers have vaccination mandates that may apply to certain GE Healthcare employees.

Relocation Assistance Provided: No

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