SUMMARY OF ROLE:The Manager, Quality Systems is responsible for day-to-day operation and continuous improvement of Element Science's Quality System. The role is responsible for Document Control, Training Program, Change Control, Internal & External Audit Program, Management Review, Nonconformance management and CAPA management. The Manager, Quality Systems serves as deputy management representative representing the organization in internal and external audits. This role serves as co-system administrator for eQMS and works with cross functional stakeholder ensuring the organization continues to maintain CHAP accreditation and in compliance with DME requirements including managing external DME audits maintaining quality documentation and ensuring adherence to regulatory standards. This role supports EU MDR deliverables in collaboration with external regulatory consultant. This role plays a key part in sustaining a compliant, audit ready QMS that upholds patient safety and organizational integrity.
RESPONSIBILITIES:- Lead, mentor, and develop Quality Systems team members, fostering a culture of quality, accountability, collaboration, and continuous improvement
- Partner cross-functionally to investigate quality issues, interpret data trends, and drive timely, risk-based decisions
- Build and maintain strong working relationships with internal stakeholders, external auditors, and regulatory partners
- Own and maintain the Document Control system, ensuring controlled documents remain accurate, current, compliant, and properly version-controlled
- Administer and continuously enhance the company training program, ensuring timely completion, training effectiveness, and maintenance of compliant training records
- Own the CAPA program, including driving timely resolution of aging CAPAs, ensuring robust root cause investigations, and monitoring closure effectiveness and metrics
- Manage Nonconformance (NC) processes from initiation through final disposition and closure, ensuring timely and compliant execution
- Lead Management Review activities, including development of quality metrics, trend analysis, and executive-ready Quality Management Review (QMR) materials
- Monitor, analyze, and trend quality system metrics to proactively identify systemic risks, drive corrective actions, and support continuous improvement initiatives
- Support post-market surveillance activities, including maintenance of associated documentation and reporting requirements
- Support EU MDR compliance activities in partnership with external regulatory consultants, including CERs, PSURs, and PMS deliverables
- Maintain quality documentation and records necessary to support BSI certification activities and ongoing CE mark compliance
- Own and execute the Internal Audit Program, including audit planning, scheduling, execution, findings management, and verification of corrective action closure
- Coordinate CHAP accreditation activities and ongoing DME compliance requirements, including preparation for and management of external audits
- Partner with external auditors and regulatory agencies to support inspections, audits, and compliance readiness activities
- Ensure the Quality Management System remains compliant with FDA, ISO 13485, CHAP, EU MDR, and other applicable regulatory and quality standards
- Support system validation activities, process improvements, and ongoing enhancements to quality systems and tools as needed
QUALIFICATIONS:- 5+ years of progressive Quality Assurance experience within the medical device industry, including experience in regulated manufacturing environments
- 2+ years of people leadership or management experience, with demonstrated ability to lead and develop high-performing teams
- Strong working knowledge of ISO 13485, 21 CFR Part 820, FDA Quality System Regulations, and EU MDR requirements
- Hands-on experience utilizing eQMS and PLM systems to support quality and compliance initiatives
- Ability to interpret, implement, and adapt to evolving regulatory requirements, including DME quality system standards
- Solid understanding of core quality processes, including CAPA, nonconformance management, complaint handling, change control, and internal auditing
- Experience partnering with external auditors and regulatory agencies, including BSI, FDA, CHAP, or equivalent organizations
- Demonstrated ability to manage multiple priorities and drive execution in a fast-paced, evolving environment
- Strong analytical and problem-solving skills, with the ability to identify trends, summarize findings, and communicate recommendations to leadership
BENEFITS:Element Science offers a very competitive salary and benefits package including, but not limited to:
- Stock Options
- 90% employer-paid medical, dental, and vision insurance
- Company-paid Basic Life Insurance
- 401(k) retirement plan (Traditional and Roth)
- Competitive Paid Time Off
- Paid Holidays
- FSA (Flexible Spending Accounts)
- HSA (Health Savings Account)
- Employee Assistance Program through PEO
The salary for this exempt-level position will be based on experience and qualifications within an established pay range.
- Pay range: $144,000 - $154,000
