QMS Release Specialist (Maternity Leave Cover)

Job Role: QMS Release Specialist (Maternity Leave Cover)

Location: Skopje

Reporting to: Software Release Manager 

Established in 1984, MAK-SYSTEM’s vision is to design, develop, and deliver globally best-of-breed software to manage Blood, Plasma, Tissue, and Cells from end to end using the best technologies and functionalities for the patient’s benefit. Our software solutions continuously support the digital transformation of organizations such as

• Blood& Plasma Centers
• Transfusion Services
• Tissue Banks
• Stem Cell Labs
• Cell and Gene Therapy (SME to Big Pharma, CMOs, Hospitals)

These software solutions can be delivered via the MAK.care global platform as Managed Services, encompassing Service Desk Support, Platform Management, Infrastructure Management, Data Protection, and Security Governance Automation.

QMS Release Specialist involves overseeing software release management to ensure timely and high-quality deliveries, while maintaining compliance with regulatory requirements for medical device records.

Key Responsibilities:

1. Software Release Management:

• Lead planning and timely software releases for multiple applications across various portfolios including maintenance patch yearly calendar.
• Measure, monitor, and report on progress to ensure releases are delivered on time and meet or exceed quality expectations per the SDLC.

2. Integrated Management System (IMS) / Quality Management System (QMS) and Medical Device Records Management:

• Collect, review, control, maintain, and store release process-related quality records in compliance with records retention policies and regulatory requirements for Device History Records (DHR), Design History Files (DHF), and Device Master Records (DMR).
• Ensure proper control and documentation of non-conforming products and actively participate in product recalls as needed in coordination with IMS/QMS Quality Assurance and Regulatory Affairs department.

3. Cross-Functional Collaboration:

• Work collaboratively with product management, customer success, technology teams, quality assurance, regulatory teams, and other stakeholders across multiple locations.
• Coordinate efforts between different teams to ensure seamless release execution and alignment with organizational goals.
• Coordinate and report on weekly release status.

4. Documentation

• Support the registration, clearance, and certification of products and the organization by contributing to necessary documentation and process readiness.
• Ensure documentation is user-friendly and supports operational excellence per applicable SOP’s and Instructions.
• Review and validate documentation for accuracy, completeness, and compliance with regulations, standards, and company policies.

5. Audit and Compliance Activities

• Prepare and organize quality documentation and materials to support the successful completion of audits, ensuring readiness and compliance.
• Support and participate in internal and external audits, ensuring timely implementation of recommendations to enhance compliance.

6. Training and Team Leadership:

• Promote a quality-first culture by increasing organizational awareness and adherence to quality standards and practices.
• Complete knowledge on SDLC, relevant regulations and standards and corresponding SOP’s.

Objectives:

• Improve Release Process: Streamline the release process to enhance efficiency, reliability, and speed.
• Enhance IMS/QMS: Continuously improve the Integrated Management System (IMS)/Quality Management System (QMS) to meet regulatory and organizational goals.
• Promote Quality Culture and Principles: Foster a commitment to quality and adherence to best practices across the organization.
• Maintain QMS Integrity: Contribute to effective audits and promptly address non-conformities to uphold standards.
• Reduce Deviations and Non-Conformance: Prevent non-conforming products from reaching customers.
• Ensure Customer Satisfaction: Deliver products that meet customer requirements and exceed expectations.
• Mentor junior team members and provide training on best practices.

Previous Experiences/Qualifications:

• Minimum 5 years’ experience working within a regulated industry in Quality Assurance (preferably medical device or pharma)
• Good knowledge of at least 3 of these standards and regulations: ISO 9001, ISO 13485, 21CFR820, FDA QMSR and EU IVDR/MDR;
• Proficiency with Microsoft Office, including Microsoft Word, Excel, PowerPoint, etc. to perform critical job functions, trending, reporting metrics etc.
• Result oriented, proactive attitude and good team player.
• Experience improving how things are done, as well as making sure they get done
• Advanced level of English, written and oral
• Ability to prioritize and work under set deadlines.

Nice to have, but not essential:

• A bachelor’s degree, preferably in a related discipline