Senior Quality Assurance Engineer
2 weeks ago
As a Senior Quality Assurance Engineer, you will play a pivotal role in developing and sustaining systems, protocols, and methodologies to ensure compliance with both internal and external standards. Your expertise will be essential in guaranteeing that projects and products adhere to specified quality benchmarks.
Key Responsibilities
- Foster a culture of quality by spearheading compliance initiatives related to specific products, locations, or regions.
- Assume responsibility for the comprehensive quality management system within the organization, while actively monitoring and enhancing quality metrics.
- Ensure adherence to quality and regulatory standards, while promoting process efficiency and effectiveness.
- Serve as the representative for GE Healthcare to external regulatory bodies, advocating for the advancement of quality culture through the execution of quality objectives, metrics, and reporting mechanisms.
- Utilize your extensive knowledge and analytical skills to implement policies and strategies effectively.
Mentorship and Leadership
- Act as a resource for less experienced colleagues, potentially leading small-scale projects with manageable risks and resource needs.
- Communicate expectations clearly and guide team members towards consensus on relevant topics.
- Handle sensitive issues with discretion and professionalism.
Autonomy and Decision-Making
- Operate with a degree of independence while adhering to established practices and policies.
- Exercise judgment to propose innovative solutions for complex, everyday challenges.
- Prioritize information effectively for data analysis, leveraging both internal and limited external resources to inform decisions.
Qualifications
- Bachelor's Degree or a minimum of 6 years of relevant work experience.
- At least 3 years of experience in a regulated medical device or pharmaceutical environment.
- Proficient communication skills in English, both written and verbal.
- Demonstrated proficiency in MS Office applications, including word processing, spreadsheets, presentations, and databases.
- Experience in project management is essential.
- Understanding of Medical Device Quality Management System (QMS) requirements and regulatory standards, including FDA CFR and ISO 13485 is highly desirable.
Preferred Attributes
- Strong verbal and written communication capabilities.
- Proven ability to analyze and resolve complex issues.
- Competence in documenting, planning, marketing, and executing programs.
- Established skills in project management.
- Experience with Corrective and Preventive Actions (CAPA) and Internal Audits.
Additional Information
GE HealthCare provides a supportive work environment, opportunities for professional growth, and competitive compensation. We are an Equal Opportunity Employer, and 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.
Relocation assistance is not provided for this position.
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