Global Quality Systems Manager

We are looking for a Global Quality Systems Manager. The role will involve anchoring all compliance initiatives and maintain expertise in applicable Quality System and Regulatory requirements for the Company, across all sites covered by the MedAlliance QMS. Play a key strategic role in extending and maintaining compliance with FDA QSR, MDR 2017/745, MDSAP, as well as supporting standards (ISO 13485, 14971, 14155), and certification audits.

Continuously maintain and improve the QMS through leading the internal audit programs, CAPA processes, and supporting supplier management, as well other Quality Management responsibilities.

Located in Irvine California. The role reports to the VP of Quality.

• Work across departments to extend or maintain compliance, driven by risk and corporate strategy; hands-on management of quality system improvement initiatives.
• Address gaps in a risk-driven manner and ensure effective remediation of related findings.
• Manage the Internal Audit schedule, and coordinate remediation actions.
• Coordinate and track the closure of CAPAs, including performance of final effectivity checks.
• Support internal and supplier audits as lead auditor, or co-auditor.
• Support and co-host audits by third parties when required, and support follow-up actions.
• Publishing progress toward achievement of all compliance improvement goals.

Strategic Impact

• Support corporate priorities through leading Quality System improvements and changes, extending the scope of our compliance while supporting lean and efficient operations.
• Contribute to maintaining and extending company certifications, by owning or supporting some core quality processes (Internal Audits, CAPAs, Supplier Management, Management Reviews).
• Support quality objectives and timelines, within the quality group and across departments.

Key Interactions

• Reports to VP of Quality
• Collaborate with all other functions on a project-basis, and through audits and CAPA processes.
• Interact with direct reports, suppliers, and other members of the local and global Management Team.

Competencies & Skills

• Strong Quality Assurance and compliance background, across multiple regulations and standards
• Relevant references include ISO 13485, ISO 14971, MDR, MDSAP, QSR.
• Proven Project Leadership, capable of planning and executing improvement initiatives.
• Strong written and verbal communication skills.
• Ability to translate requirements into a practical process adapted to a team’s needs.
• Confident personality with an ability to make independent, risk-based decisions.
• Certification for ISO 13485 Lead Auditor (preferred).

Work Experience & Qualification

• Bachelor’s Degree in a Scientific Discipline
• Minimum of 5 years’ experience with current U.S, EU and international medical device regulations in a Class III medical device company
• Experience in successfully implementing process changes, from gap analysis to VoE and monitoring.
• Experienced Quality Auditor with a minimum of 3 years of experience (internal and supplier audits).
• Experience with hosting or participating in FDA and ISO audits.
• Prior CAPA program management is preferred.

How to Apply

If you would like to apply for this role and have the relevant experience and qualifications please send an email quoting “Global Quality Systems Manager” in the email subject. Please attach your CV and a Covering Letter (max 1 page) explaining why you feel you would be suitable for the position.

Please email to: careers-usa@medalliance.com.