Quality Manager (Medical Device)

What you'll do:

• Ensure comprehensive compliance with regulatory requirements and internal procedures by supporting notified body inspections and regulatory audits.
• Articulate and exemplify a clear vision for quality at both strategic and operational levels, inspiring your team to embrace best practices.
• Support daily quality functions within manufacturing operations, maintaining exemplary standards throughout production processes.
• Provide coaching and developmental guidance to your team of leaders, enabling them to leverage their individual strengths for collective benefit.
• Serve as the Management Representative responsible for ensuring facility adherence to internal policies, customer requirements, and divisional quality systems.
• Monitor Key Performance Indicators (KPIs) related to quality performance and drive continuous improvement initiatives informed by data analysis.
• Ensure compliance with cGMP, ISO standards (including ISO 13485), FDA regulations, ISO 14971, and other pertinent international standards.
• Act as a communication liaison between customers and the manufacturing facility to ensure expectations are consistently met or exceeded.
• Participate in continual improvement activities such as corrective actions, innovation projects, and internal/external customer satisfaction programmes.
• Contribute meaningfully to creating a safe, inclusive workplace environment where all voices are respected.

What you bring:

• A Bachelor’s degree or higher in a scientific discipline is required to ensure foundational knowledge relevant to medical device manufacturing.
• At least five years’ experience in Quality Assurance within the medical device or biotechnology industry demonstrates your familiarity with regulated environments.
• A minimum of five years’ management experience equips you with proven leadership abilities for coaching teams towards shared objectives.
• Proficiency in quality management tools such as risk assessment methodologies (FMEA), root cause analysis techniques, technical writing skills, and statistical tools ensures robust process validation.
• Strong analytical skills enable you to interpret complex data sets for trend identification and decision-making regarding process improvements.
• Demonstrated experience with quality system requirements for regulated products including ISO 13485, FDA Quality System Regulations, ISO 14971, as well as other international standards is essential.
• Competency in managing regulatory inspections/audits along with developing effective response strategies evidences your capability under scrutiny from authorities.
• Effective cross-functional collaborator who works harmoniously with teams such as Regulatory Affairs and Operations enhances organisational synergy.
• Ability to act as a communication liaison between customers/manufacturing facilities ensures clarity around expectations and satisfaction levels.
• Experience contributing to safe/inclusive workplaces highlights your commitment to positive organisational culture.

What sets this company apart:

This organisation distinguishes itself through its steadfast commitment to product excellence within the medical device sector. Employees benefit from an inclusive culture that prioritises safety alongside professional development opportunities such as structured coaching and mentoring programmes designed to facilitate individual growth. Cross-functional collaboration is encouraged at every level—whether between site functions or across global entities—ensuring that each employee feels connected to broader organisational objectives. The company’s dedication extends beyond mere compliance: it actively pursues avenues for enhancing customer satisfaction through innovative solutions whilst maintaining rigorous standards set by international regulators including ISO/FDA/notified bodies. Here you will find a supportive network where contributions are valued equally irrespective of seniority; everyone has access to resources necessary for personal and professional advancement. The focus on continual improvement empowers employees not merely to maintain but also enhance quality outcomes—rendering this an ideal environment for those who wish their work acknowledged within a respected industry leader.

What's next:

If you are prepared to elevate your expertise in quality management within an inclusive medical device manufacturing environment, this represents an outstanding opportunity.

Apply today by clicking on the link provided.