Manager, Quality Compliance

integralife; Freiburg; Vor Ort; CHF 130.000 - 170.000; Vollzeit

Jobbeschreibung

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

The Quality Compliance Manager is responsible for overseeing all Quality Management System activities, including CAPA management, site quality metrics, document control, training programs, internal and external audits, quality plans, health hazard evaluation, complaint trend analysis and complaint handling, ensuring compliance with Quality, Environmental, Health & Safety policies and procedures.

RESPONSIBILITIES

Complaint Management

• Lead and oversee the Medical Device Complaint Management process, including complaint evaluation, investigation, and assessment of returned product samples.
• Ensure complaints are appropriately triaged, investigated, documented, and closed within established timelines.
• Drive root cause investigations and risk assessments to identify systemic issues and ensure product quality and patient safety.
• Ensure timely escalation and management of critical quality and safety-related issues.
• Oversee complaint laboratory activities, ensuring equipment is maintained, calibrated, qualified, and operated in compliance with applicable procedures.
• Define, monitor, and report complaint management KPIs, ensuring effective communication with key stakeholders.

Audit Management

• Manage the Site Internal Audit Program and ensure its effective implementation.
• Develop and maintain the annual audit schedule in compliance with corporate and regulatory requirements.
• Assign qualified auditors and ensure adequate audit coverage across all relevant processes.
• Maintain compliance with applicable standards and regulations, including ISO 13485, FDA 21 CFR Part 820, EU MDR, and other relevant regulatory requirements.
• Ensure auditor qualification, competency, and ongoing development.
• Monitor audit findings, nonconformities, and continuous improvement opportunities, ensuring timely implementation and verification of corrective actions.

Quality Systems, Compliance & Regulatory Support

• Ensure compliance with Quality, Environmental, Health & Safety policies and procedures, ISO 13485 requirements, applicable pharmacopoeias, and regulatory standards.
• Support Management Reviews and contribute to the achievement of Quality Objectives.
• Lead and support regulatory, certification, customer, and internal audits and inspections.
• Contribute to the development, implementation, maintenance, and continuous improvement of quality procedures, work instructions, and policies.
• Coordinate Health Impact Assessments in collaboration with Design Quality Assurance, Regulatory Affairs, Corporate Quality, and other cross-functional stakeholders.

Training Management

• Manage and maintain the Learning Management System (LMS), including training assignments, records management, and data integrity.
• Ensure training compliance and support employee qualification requirements across the site.

Document Control

• Manage and maintain the site Document Control System within the PLM environment.
• Ensure controlled documentation is reviewed, approved, distributed, and archived in accordance with established procedures.
• Support the implementation and continuous improvement of document control processes and systems.

CAPA Management

• Own and oversee the site CAPA process, ensuring timely and effective execution of corrective and preventive actions.
• Ensure CAPA activities comply with applicable regulations, quality standards, and internal procedures.
• Facilitate CAPA Review Board meetings and drive accountability for CAPA completion.
• Monitor, analyze, and communicate CAPA process performance metrics to management.
• Promote the effectiveness and continuous improvement of the CAPA system.

Team Leadership & Resource Management

• Lead, coach, and develop a multidisciplinary team of Quality Engineers and Quality Technicians.
• Allocate resources and manage priorities to support operational, compliance, and project objectives.
• Establish, monitor, and evaluate individual performance objectives aligned with company goals and organizational strategy.
• Foster a culture of accountability, collaboration, engagement, and continuous improvement.

Continuous Improvement

• Identify and drive quality system and process improvement initiatives to enhance compliance, efficiency, and effectiveness.
• Support site-level operational excellence initiatives and cross-functional projects.
• Promote a proactive quality culture focused on compliance, risk management, and continual improvement.

QUALIFICATIONS

• Minimum of a Master's degree in a Life Sciences discipline.
• Strong knowledge of medical device standards and regulations, including ISO 13485, 93/42/EEC, EU MDR, and 21 CFR Part 820, Canadian, Japanese, Australian, Brazilian regulations, etc.
• Minimum of 10 years professional experience in medical device or pharmaceutical manufacturing environments.
• Strong management and leadership skills, with experience supervising laboratory teams.
• Excellent communication, organizational, negotiation, and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Fluent in English and French
• Ability to collaborate effectively with all levels of management across multiple sites and functions.