QA Coordinator

Senzime - A global medical device company

Senzime is a global medical device company drivning a technological paradigm shift with innovative patient monitoring systems, targeting a market opportunity valued at more than SEK 40 billion in the US and Europe.

Our success is built on the strength of our team. We believe in fostering a culture of transparency, integrity and accountability, we are committed to creating a workplace where everyone feels heard and valued.

Join Our Team as a QA Coordinator

Are you passionate about quality assurance and quality control? Do you have experience in the medical device or within Life Science? We are looking for an energetic QA Coordinator with good collaboration skills to join our dynamic team.

About the Role: As a QA Coordinator, you will oversee various aspects of the Quality Management System (QMS) and ensure quality assurance within our operations department. You will report directly to the Head of QA/RA/S and play a crucial role in maintaining high standards of quality.

Key Responsibilities:

• Product Release Post-Manufacturing and Service: Ensure products are released after manufacturing and service.
• Incoming Inspection: Perform incoming inspection of products.
• Customer Complaints Handling: Address and manage customer complaints.
• Documentation Management: Handle and manage all relevant documentation.
• Non-Conformance and CAPA: Follow up, handle, and approve non-conformance and corrective actions.
• .Concessions and Rework: Review, follow up, and approve concessions and rework.
• Audits: Participate in and prepare for audits, capture required improvements, and handle related non-conformance.
• Validation: Validate equipment, software, and processes from a QA perspective.
• Annual Preparations: Conduct annual document reviews, prepare for management reviews, quarterly meetings, and annual updates for year-specific documents.
• Manufacturing Documentation: Review and create manufacturing documentation.
• QMS Document Handling: Manage and control QMS documents.

Qualifications:

• Minimum 5 years of experience with product release and document handling in the medical device or Life Science Industry.
• Proficiency in Microsoft Office (Excel, Word, Outlook).
• Meticulous attention to details.
• Good writing skills in both Swedish and English.

What We Offer:

• A challenging and rewarding work environment.
• Opportunities to influence and contribute to the company's future development.
• Opportunities for further education and professional growth.
• A supportive and inclusive company culture.

Are you ready to take the next step in your career and join our fantastic team?

Please send in your application as soon as poosible, at the latest June 9th,as interviews are being conducted on continuous basis.