The Senior Manager, Quality Systems is responsible for overseeing the planning, management and development of corporate policies and procedures for multiple Quality Systems teams. This role will serve as a point of escalation for activities related to quality system compliance, including assessment, oversight and definition, and the structure and continuous improvement of the Endologix Quality Management System (QMS). In addition, this role frequently takes the lead for externally facing responsibilities with regulators and notified bodies.
Responsibilities
Develop, recommend and execute organizational strategies to safeguard the Endologix brand and reputation using the Quality System tools and processes.
Collaborate on strategy and drive planning for Internal Audits and External Audits, Documentation and Records Management, Labeling, CAPA, Training and Software Quality
Maintain and monitor software systems used for quality activities like Trackwise and MasterControl software systems.
Translate business strategy into operational priorities for compliance, data management/communications, and system architecture.
Build upon existing organizational compliance capabilities:
Identify and drive opportunities for Quality System improvements
Develop and enforce policies and procedures to standardize compliance where possible.
Chair/lead (as directed and when determined necessary) the Quarterly Management Review meeting.
Shape values and reinforce a culture of Quality and Compliance which includes:
discipline
data driven decision making
problem solving tool usage and training
Appropriately staff areas of responsibility and respond to business needs.
Build leadership capabilities:
Select, develop, and mentor managers and individual contributor level staff.
Assess turnover and retention strategies that deliver on long-term results for the organization.
Represent Endologix QMS activities with external regulators and notified bodies during inspections or audits
Act as a key decision-maker for Quality and Compliance functions.
Collaborate with executive and Quality leadership to identify, develop, implement and/or resolve Quality and Compliance challenges to increase operational success.
Perform other duties as assigned by leadership.
Travel to Endologix manufacturing sites in California and partner locations domestically and internationally up to 20% of the time.
Qualifications
General Qualifications:
Demonstrates an expert understanding of and ability to interpret regulations and guidelines governing medical devices including QSR's, ISO 13485, CMDR, MDD, MDR and JPAL.
Strong communication and people management capabilities. Ability to lead change through education, sales, and negotiation skills.
Proven managerial and leadership skills leading to consistent improvement in team performance, process capability, and product quality
Excellent judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Excellent analytical and decision-making skills.
Experience in a fast-paced remedial environment leading to rapid growth.
A balck belt certification is preferred.
Education and Experience:
A Bachelor's degree in a technical discipline is required.
Master's Degree preferable.
ASQ Certification in any of the Quality Disciplines strongly desired.
Training on regulated industry quality management desired.
Minimum of 7 years of experience in the medical device industry with progressive experience in quality or related technical capacity
Minimum of 5 years of progressive leadership experience in Quality preferably in the medical device industry
Demonstrated experience and success in the application of Quality Management System principles
Demonstrated experience and application of US and International Medical Device regulatory schemas and standards, such 21 CFR Part 7, 21 CFR Part 803, 21 CFR Part 806, and 21 CFR Part 820, EU Medical Device Regulation (MDR), Medical Device Single Audit Program (MDSAP)
Demonstrated experience in communicating successfully with regulatory agencies such as: FDA, PMDA, MHLW, TGA, Notified Bodies, Competent Authorities
