Quality Compliance Specialist

hace 3 meses

Valencia, Valencia, España Edwards Lifesciences A tiempo completo

Role Overview:
As a Quality Compliance Specialist, you will ensure adherence to relevant medical device regulations and standards, including ISO13485, within the designated complaint handling unit. Your expertise will be vital in evaluating events for their reportability to regulatory authorities.

Key Responsibilities:
• Conduct thorough investigations of complaints involving moderately complex scenarios:
- Assess events to determine if they meet the criteria for a complaint.
- Maintain effective communication with customers throughout the complaint investigation and resolution process.
- Analyze complaint data and perform additional inquiries as necessary, escalating issues when appropriate.
- Collaborate with Product Safety, Engineering, and other departments to gather insights for complaint investigations.
- Evaluate complaints for Medical Device Reporting to relevant authorities.
- Prepare and submit reports to regulatory bodies, subject to review by senior team members.
- Summarize investigation findings, including product analysis and relevant documentation, to draw informed conclusions.
- Draft and finalize customer correspondence, ensuring it is reviewed by senior team members.

• Facilitate meetings to discuss complaint issues with various functions (e.g., Manufacturing, Quality Assurance, Suppliers) to identify root causes and resolve outstanding action items.
• Identify process improvement opportunities and lead projects aimed at enhancing procedures and practices, proposing innovative solutions to encountered challenges.
• Undertake additional tasks as assigned, which may include auditing complaint files and generating reports.

Qualifications:
• Bachelor’s Degree in a related field.
• Minimum of 3 years of experience in complaint handling or a similar role, preferably within the medical device sector (cardiovascular, endovascular, or critical care/surgical products).

Desired Skills:
• Proficiency in MS Office Suite and familiarity with general office equipment.
• Strong written and verbal communication skills, along with excellent interpersonal abilities.
• Demonstrated problem-solving, critical thinking, and investigative skills.
• Comprehensive understanding of Edwards policies and quality compliance guidelines.
• Familiarity with medical terminology and human anatomy.
• Knowledge of Medical Device Vigilance regulations and reporting requirements.
• Understanding of Good Documentation Practices (GDP) related to complaint management.
• Ability to handle confidential information with care and discretion.
• Strong attention to detail and the capacity to manage competing priorities in a dynamic environment.
• Collaborative mindset with the ability to work effectively in inter-departmental teams and represent the department on specific projects.
• Commitment to fostering productive relationships with internal and external stakeholders.

Work Environment:
At Edwards Lifesciences, we are dedicated to creating a diverse and inclusive workplace where all employees can thrive. We offer a supportive environment that encourages personal and professional growth through on-the-job development and training opportunities.

Benefits:
• Competitive compensation and benefits package.
• Flexible working hours and remote work options.
• Pension plan and life insurance.
• Comprehensive medical plan and meal vouchers.
• Employee stock purchase program and assistance programs.
• Wellness initiatives, including gym membership reimbursement and mindfulness sessions.

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