Quality System & MDR Certification Coordinator

Avomind; Großostheim; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Santec seeks a Quality Management System owner to drive MDR certification initiatives, maintain comprehensive QMS documentation, and lead the CAPA program in a fast-paced medical devices environment in Germany. You will coordinate cross-functional teams and ensure traceability across four workstreams for timely reviews.

The ideal candidate has 3–5 years in regulated industries, strong ISO 13485/MDR knowledge, and fluent German with English proficiency.

Qualifikationen

• Engineering, science, or business administration degree.
• 3–5 years in medical devices or a regulated industry (pharma or automotive acceptable).
• Familiarity with ISO 13485 and Regulation (EU) 2017/745 (MDR); auditor qualifications not required.
• Languages: native German or C1+ German, plus B2 English or higher (Spanish desirable).
• Tools: PM tools (MS Project/Planner or equivalent) and advanced Excel skills.

Aufgaben

• Operational ownership of the QMS: manage information, documentation, records, and end-to-end traceability.
• Coordinate MDR certification timeline, gap analysis, and documentation package.
• Active CAPA plan management with owners, due dates, and dashboards.
• Prepare monthly dashboards for four workstreams and 60-minute reviews.
• Bilingual DE/EN document control templates and workflows.
• Audit logistics and documentation packages for internal and MDR audits.
• Local PMS data capture feeding Regulatory Affairs and Business Development deliverables.
• Transactional support: purchasing/logistics admin for quality projects.

Kenntnisse

QMS ownership

MDR certification

CAPA management

Document control

Project management

Ausbildung

Engineering/Science/Business degree

Tools

MS Project

Planner

Excel

Jobbeschreibung

Our client is a renowned international player in the production, advisory services, and sales of specialized medical products, with a portfolio across cardiovascular, ophthalmic, microsurgery, plastic, orthopedic, dental & maxillofacial surgery, and other surgical specialties.

It is a proudly Mexican company with more than 56 years of history, built on strong values of ethics, excellence, innovation, and commitment to healthcare.

They manufacture high-quality surgical sutures and medical devices, contributing to the care of millions of patients in Mexico and in more than 80 countries worldwide. With over 900 employees, they have been the leading supplier of surgical sutures to the Mexican Public Health Sector for more than 30 years and are ranked among the top ten companies globally in our segment.

The position is responsible for the information, documentation, and processes of Santec’s Quality Management System (QMS). Under the direction of Quality Management, the role assumes operational ownership of the QMS—not merely coordination—thereby enabling Quality Management/PRRC to focus on technical judgment and regulatory decision-making. This is the management and execution function currently missing at Santec, providing structure, momentum, and traceability across the four workstreams of the 2026-2027 plan (foundation, MDR portfolio, braided products, and ePTFE), with an explicit priority on the MDR workstream.

Key Responsibilities

1. Operational ownership of the Quality Management System: Manages QMS information, documentation, records, and end-to-end traceability; serves as the single point of control for quality documentation.
2. MDR Certification (priority objective): Develops and executes the certification timeline, coordinates the gap analysis, integrates the documentation package, and follows up on the closure of findings with the certification body through successful certification.
3. Active CAPA Plan: Assigns owners and due dates, conducts biweekly follow-up, and maintains a progress dashboard; escalates delays to Quality Management and, in critical cases, to General Management.
4. Timelines and monthly dashboard for the four workstreams (foundation, MDR portfolio, braided products, and ePTFE) for the 60-minute review with Quality Management and General Management.
5. Bilingual DE/EN document control: Templates, approval workflows, and audit-ready documentation files.
6. Audit logistics and documentation packages (internal audits, scope extensions, surveillance audits, and MDR audits), in coordination with Quality Management.
7. Local documentary execution of PMS (Post-Market Surveillance): Captures the data and records that feed the deliverables of Regulatory Affairs and Business Development (IFSA).
8. Transactional support: Handles purchasing/logistics administrative tasks related to quality projects, relieving Operations of these activities.
   

First 6-Month Deliverables

• Approved MDR certification master plan by Quality Management, including timeline, gap analysis, and identified open findings (October 2026).
• Four-workstream dashboard fully operational, with monthly review established (November 2026).
• Up-to-date CAPA plan, with critical CAPAs closed by November 30, 2026.
• ISO 13485 scope extension application submitted to the certification body (December 2026), including the complete documentation package, as an enabler for MDR certification.
• Bilingual DE/EN template system published and in use by Quality and Production.
  

Requirements

• Education: Engineering, science, or business administration degree.
• Experience: 3-5 years in medical devices or a regulated industry (pharmaceutical or automotive experience acceptable), in coordination, quality, or PMO roles. Previous experience participating in MDR certification processes or ISO 13485 audits is a plus.
• Knowledge: Practical knowledge of ISO 13485 and familiarity with Regulation (EU) 2017/745 (MDR). The position does not require auditor qualifications or responsibility for regulatory decisions; this authority remains with Quality Management/PRRC.
• Languages: Native German or C1+ German, plus B2 English or higher; Spanish is desirable for interaction with IFSA.
• Tools: Project management tools (MS Project, Planner, or equivalent) and advanced Excel skills.
  

Competencies and Selection Criteria

Impeccable organization and strong follow-through without full hierarchical authority over all areas: the role will need to secure commitments from people who do not report directly to them and maintain progress on a regulatory certification process (MDR) involving multiple internal and external stakeholders. A high tolerance for detailed documentation is essential.

During the interview, candidates should be asked for specific examples of tracking systems they have built and maintained for more than one year, how they ensure that others meet deadlines, and their direct experience—if any—with certification processes or regulatory audits.

Natural Career Progression

Reports directly to Quality Management, with the potential to lead the Quality function as the certified MDR product portfolio grows.