Quality Manager - Medical Device/Pharmaceutical Manufacturing

Role Overview

We are seeking a seasoned Quality Manager to join the leadership team of a prominent manufacturing site specializing in medical devices and pharmaceuticals. This key leadership role involves overseeing the Quality function to ensure compliance with global regulatory standards, bolster operational excellence, and foster a culture of continuous improvement.

Key Responsibilities

• Ensure the site upholds a comprehensive Quality Management System and meets regulatory mandates including ISO 13485, FDA Quality System Regulations, GMP, and customer-specific requirements.
• Lead and nurture the onsite Quality team, providing direction and mentorship.
• Establish and execute the site's quality strategy and continuous enhancement plans.
• Manage the Quality Management System's maintenance and ongoing improvement initiatives.
• Control quality-related budgets and focus on mitigating risks and costs associated with quality issues.
• Serve as the site’s Management Representative, leading management review processes.
• Drive Corrective and Preventative Action (CAPA) processes and coordinate root cause investigations.
• Handle customer complaints and oversee resolution of quality issues.
• Lead the internal audit program and facilitate external audits successfully.
• Ensure robust change control procedures are implemented and complied with.
• Develop, analyze, and report key quality performance indicators and trends.
• Champion continuous improvement activities site-wide and promote a strong quality-first culture.
• Collaborate with the broader leadership team to achieve strategic and operational objectives.

Candidate Profile and Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• Approximately 5 to 8 years of quality leadership experience within medical devices or closely related regulated manufacturing fields.
• Proven track record in working within regulated manufacturing environments.
• In-depth understanding of Quality Management Systems, regulatory compliance, and operational leadership.
• Hands-on experience in ISO 13485 and FDA-regulated settings.
• Demonstrated ability to lead quality teams and enhance performance metrics.
• Strong analytical and problem-solving aptitude focused on root cause analysis.
• Exceptional communication and stakeholder engagement skills.
• Preferred additional qualifications: Master’s degree or further relevant certifications, Six Sigma or continuous improvement experience, Certified Quality Auditor credential, familiarity with ISO 14971, and experience managing regulatory/customer audits.

What We Offer

This senior leadership opportunity includes a competitive salary and an attractive benefits package, presenting an excellent platform to influence quality across a respected organization.