Peters Surgical is a distinguished French multinational company that has been establishing its foothold in the medical device sector since 1926. Recognized as a global leader, Peters Surgical boasts an impressive turnover of €82 million and maintains a significant presence in six countries, serving over 90 countries worldwide. The company specializes in two critical therapeutic areas: cardiovascular (CV) and surgical specialties. Its product range includes sutures, clamps, clips, meshes, surgical glue, and laparoscopic instruments, all aimed at enhancing the quality of patient care.
Key Responsibilities
As a Quality Management Specialist at Peters Surgical, your role will encompass a variety of responsibilities related to quality management systems, quality assurance, and regulatory affairs. The position requires a keen understanding of ISO 13485:2016 standards and the following key responsibilities:
- Quality Management System Activities
- Manage all activities related to the Quality Management System (QMS), including documentation and compliance.
- Prepare and maintain QMS documentation, ensuring adherence to regulatory standards.
- Technical File Development
- Create and update technical files that include essential components like risk management, clinical evaluations, post-market surveillance, and quality plans.
- Ensure that all technical documentation is current and compliant with necessary regulations.
- Audit Coordination
- Organize internal and external audits, including audits by notified bodies related to the quality management system and CE marking.
- Follow up on non-conformance reports to ensure resolution and compliance with quality standards.
- Customer Complaints and Vigilance
- Address customer complaints promptly, conduct thorough investigations, undertake root cause analysis, and provide detailed responses.
- Manage vigilance reporting and product recalls as necessary, ensuring compliance with regulatory requirements.
- Management Review Meetings (MRM)
- Organize Management Review Meetings and ensure that actions from previous meetings are followed up and completed effectively.
- Document minutes of meetings and track progress on action items.
- Standard Operating Procedures (SOPs) and Manuals
- Review and modify all Standard Operating Procedures and quality manuals to maintain relevant and compliant practices.
- Ensure that all team members are trained on updated procedures.
- Record Management
- Establish and maintain a master list of records and documents, including updates as necessary to reflect changes within the organization.
- Manage deviations and maintain corresponding records.
- Corrective and Preventive Actions (CAPA)
- Implement and maintain corrective and preventive actions, ensuring that monitoring systems are in place.
- Document all corrections and follow-ups as part of the continuous improvement process.
- Pre-dispatch Inspections
- Manage pre-dispatch inspections of shipments coordinated with external agencies and certification bodies.
- Ensure compliance of shipments with established quality standards before dispatch.
- Training and Development
- Plan and conduct training sessions for employees on quality management practices and regulatory compliance.
- Stay updated with industry regulations and methodologies to effectively impart knowledge to team members.
Qualifications
To be considered for the position of Quality Management Specialist, candidates should possess the following qualifications and skills:
- A degree in a Science-related field (Bachelor’s degree preferred).
- A minimum of 2-4 years of experience in medical device manufacturing, with a solid understanding of manufacturing methods and quality standards.
- Proficient computer skills, including experience with quality management software.
- Excellent communication skills, with the ability to clearly explain methodologies and train others effectively.
Why Join Peters Surgical?
Joining Peters Surgical means being part of a reputable company dedicated to improving healthcare outcomes through innovative medical devices. We offer a dynamic work environment that encourages professional growth and development. You will collaborate with a team of dedicated professionals committed to quality and patient safety in the medical device sector.
If you are a motivated individual with a passion for quality management and a desire to make a difference in patient care, we encourage you to apply for the Quality Management Specialist position at Peters Surgical.
In summary, this role offers an exciting opportunity to work within a leading company in the medical device industry, enhancing your career in quality management while contributing significantly to the advancement of patient care practices worldwide.
