QUALITY/ COMPLIANCE MANAGER

Pracovní nabídka

JOB VACANCY: QUALITY/ COMPLIANCE MANAGER

Location: Litovel, Czechia

Company: Confitex Technology EU

Job Level: Senior

Employment Type: Full-time, On-site

Reports to: General Manager – E.U.

JOB SUMMARY:

▸ Confitex Technology EU is seeking an experienced and detail-driven Quality / Compliance Manager to lead our Quality Management System and regulatory compliance function at our manufacturing facility in Litovel, Czechia.

▸ This is a senior, independently-reporting role holding the legally mandated position of Person Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15, with organizational authority to stop product release, initiate CAPA and change control actions, and escalate quality or safety concerns directly to top management.

▸ Confitex is the world's only specialist private-label reusable absorbent hygiene manufacturer, and one of the few with ISO 13485 certification for medical-grade incontinence products, serving leading global retailers and category brands.

KEY RESPONSIBILITIES

Quality Management System & Regulatory Compliance

▸ Establish, implement, maintain, and continuously improve the QMS in compliance with ISO 13485 and applicable regulatory frameworks (MDSAP, MDR, CE, Oeko-Tex Standard 100, STeP by Oeko-Tex, GOTS certificate and others).

▸ Plan and conduct internal audits; support external audits by certification bodies and regulatory authorities. Creates additional records, controls and checklist to address customer specific QC requirements. Leads the implementation of SPC for the quality control function and periodically coordinates and documents reviews and trend analysis with key participants.

▸ Manage CAPAs, nonconformities, deviations, and change control; drive continuous process improvement. Leads the preparation of the site’s FMEA, coordinates the internal annual audit program as well as documenting SCAR’s from suppliers when applies.

▸ Act as primary contact for Notified Bodies, certification bodies, and regulatory agencies; actively interacts with INDA and EDANA nonwoven organizations.

▸ Monitor regulatory changes and ensure timely implementation; support product registrations and communication with competent authorities.

▸ Oversee supplier qualification, monitoring, validation, and verification activities. Interacts with CONFITEX’s plant in other regions, comparing systems, ensuring alignment in systems and QA procedures.

▸ Prepare and coordinate Management Reviews; promote a culture of quality and compliance across the organization. Co participates in the implementation of site’s “eQMS”.

▸ Oversee the Quality function, including team development, inspection and testing strategies, calibration of measuring equipment, and risk management per ISO 14971.

Person Responsible for Regulatory Compliance (PRRC) – EU MDR 2017/745, Article 15

▸ Ensure device conformity is appropriately checked prior to release.

▸ Ensure technical documentation and EU declarations of conformity are drawn up and kept up to date.

▸ Ensure Post-Market Surveillance obligations are fulfilled and reporting obligations for serious incidents and field safety corrective actions are met.

▸ Maintain communication with external parties on QMS matters as Management Representative (ISO 13485:2016, Clause 5.5.2).

▸ Report to top management on QMS performance and improvement needs (ISO 13485:2016, Clause 5.5.2(b)).

People & Team Leadership

▸ Lead, manage, and develop the Quality team, including Quality Inspectors, Laboratory & Metrology personnel, and Document Control specialists.

▸ Define clear roles, responsibilities, and performance objectives; conduct regular one-to-ones and performance reviews.

▸ Ensure team competency and qualification levels meet regulatory and operational requirements; maintain training records per ISO 13485.

▸ Foster a positive, high-performing team culture built on open communication and cross-functional collaboration.

REQUIRED EXPERIENCES AND SKILLS

▸ 5+ years' experience in a senior Quality Assurance / Regulatory Affairs role within medical device manufacturing.

▸ University degree required, ideally in engineering, life sciences, quality management, or a related scientific discipline.

▸ Meets the PRRC qualification requirements of EU MDR Article 15 (relevant degree plus professional experience in regulatory affairs/QMS for medical devices, or equivalent extensive professional experience).

▸ Strong working knowledge of ISO 13485, EU MDR 2017/745, MDSAP, and CE marking requirements; familiarity with Oeko-Tex Standard 100 and STeP by Oeko-Tex is an advantage.

▸ Proven track record managing CAPA processes, internal/external audits, and relationships with Notified Bodies and regulatory authorities.

▸ Prior experience acting as PRRC or Management Representative in a regulated manufacturing environment is highly desirable.

▸ Demonstrated experience leading and developing a Quality/Compliance team.

▸ Fluent in both English and Czech (essential).

▸ A Six Sigma Black or Green Belt certification is not mandatory but would be advantageous for the successful applicant.

BENEFITS

▸ Performance-based annual bonus

▸ 20 days paid annual leave, increasing to 25 days

▸ Meal vouchers or subsidised canteen

▸ Professional development support, including certification and training (e.g. ISO 13485 lead auditor)

▸ Employee development programmes and continuous education support

▸ Relocation assistance (if applicable)