Sr Quality Manager

Recruiter: Spencer Gregory Hale

 

Sr Quality System Manager – Field Action Steward

 

About This Role:

Primarily responsible for managing the field action process (i.e. recalls/removals, safety alerts, customer notifications, field corrections) for the corporation and provides field action strategy expertise to the business, Quality Business Process Leads, and Regional Field Action Coordinators. This candidate will have oversight of the management of field action execution to ensure compliance to internal procedures and regulatory requirements (FDA 21 CFR Part 7 and Part 806).

 

Manage and partner with the Corporate Field Action Steward in development and maintenance of quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of processes and systems conform to establish standards and agency guidelines. Ensures appropriate quality system processes are maintained and followed in support of Corporate and Site quality objectives.

 

Work Mode: Hybrid

 

Your responsibilities will include:

• Manages field action process and/or provides oversite from initiation to closure for all field actions globally.
• Lead and mentor Global Field Action Team through field action execute to ensure timeliness while maintaining high-quality standards.
• Has oversight on determination of ship history, finalization of customer communication package, and execution activities within the US including sending notification packages to customers.
• May coordinate and support planning, communication, coordination and execution of field actions as needed.
• Support Corporate and site level internal and external audit as needed. Provide guidance and expertise regarding audit strategies and approaches.
• Mentors Corporate Field Action Steward to create and champion improvement in the field action process and all related SOP’s and business processes.
• Implements training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Ensures implementation of field action processes and other functional excellence initiatives in Quality, including integration activities.
• Remains current on all quality systems regulations for all regulatory agencies related to field actions.
• Acts as a CAPA owner/manager approver for corrective actions necessary to improve the global processes as appliable within the global processes

 

What we're looking for in you:

Minimum qualifications:

• Bachelor’s degree in relevant field and 7+ years field action experience or equivalent experience
• 4 years of people leadership experience 
• Proven leadership success through direct supervisory experience or experience leading cross-functional teams, implementing strategies, and achieving measurable results
• Understanding of regulations and standards applicable to Global Quality System and Field Action processes (ISO 13485, 21 CFR 820, EU MDR, etc.)

 

• Strong verbal, written communication skills, both technical and conversational
• Ability to work well under pressure, with multiple high priority deliverables
• Experience with major systems (e.g. CAPA, Windchill, VIP) desirable
• Decision making and negotiation skills, individually and within groups
• Strong presentation skills and MS Office skills
• Decision making and negotiation skills, individually and within groups
• Experience in managing multiple projects across multiple organizational disciplines

 

Preferred qualifications: