RA / QA Manager

Responsibilities

• Leads and participates in formal problem-solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes and Client-side findings.
• Supports the Director, RAQA for all Quality and Regulatory strategy plans, actions, implementation and upskilling as the Business grows.
• Leads overall site compliance efforts, including, but not limited to :
• Support for regulatory meetings with FDA.
• External health authority inspections and audit readiness and logistics.
• Front room audit host, RA / QA Subject Matter Authority, and / or backroom support.
• Key liaison for agency communications as the need arises.
• Lead followup activities for post-inspection root cause and correction action plan for identified corrections.
• Completion of essential functions includes the effective application of : Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, the determination of Operating Characteristics for Sampling Plans, and statistical analysis to effect quantifiable product and process improvements.
• Fulfills QA / RA subject matter authority role for all functional areas.
• Maintains Risk Management conformance to 14971 requirements, including governance of risk tools such as FMEA, Hazard Analysis, Risk-Benefit, etc.
• Drives effective and efficient improvement of inspection and test methods, sampling plans, and process control plans.
• Prepares and conducts training sessions and presentations in support of quality objectives.
• Actively participates in new product development teams and sustaining design change activities and fulfills RA / QA required actions.
• Lead the site CAPA system and ensure effective CAPA Review Board.
• Lead all aspects of the Complaint system for timely complaint handling and MDR reporting ability.
• Maintains applicable licenses and registrations to support global market.
• RA / QA review for customer-facing marketing materials per FHS processes.
• Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions.
• Supports all facets of the supplier qualification and audit system including scheduling, auditing, reporting, and corrective actions with follow-ups.
• Maintains a professional working relationship with internal and external customers and support staff.
• Provide metrics to Leadership for overall compliance initiatives and report on health of the QMS.
• Actively lead, support, mentor and develop RA / QA team members and others as needed.
• Provide resource assignments across team members to support all cross functional business activities.

Qualifications