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

• Bachelor’s degree (B.S. or equivalent experience) in engineering or science field from a four-year college or university.
• Consistent track record to lead, grow in a Leadership position, and enable Team members to grow as well.
• Minimum of seven years’ experience in Quality Assurance and three years’ experience in Regulatory Affairs in an FDA regulated industry.
• Four year’s people management experience. Track record of building and leading high-performance teams.
• Working knowledge of Quality Management Systems –. 21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments.
• Marked ability to learn new applicable standards, resolve how they apply to the Business and provide related guidance cross-functionally.
• Strong interpersonal skills with the ability to be a standout colleague and Leader; setting a professional tone and establishing a collaborative partnership within the department and other areas of the Company to optimally resolve problems.
• Ability to interpret trends and data, translating the information into actions, outcomes, and improvements.
• Excellent documentation skills, with a proven process orientation and effective attention to detail.