Biomerics

Director

• Partner with leadership to resource, execute, and enforce business goals while aligning with ISO 13485, 21 CFR 820, ISO 14971, and global regulatory standards
• Own and uphold site-level QMS compliance with customer quality requirements, registrar standards, and regulatory agency mandates
• Serve as Management Representative and drive FDA/Notified Body audit readiness
• Participate in centralized Hub-and-Spoke CQP harmonization sprints
• Direct rapid resolution of non-conformances through root-cause-driven CAPAs
• Institutionalize systemic lessons learned across multi-site operations
• Measure Quality KPIs and drive quality performance with manufacturing, divisional operations, and quality leaders
• Design, deploy, and maintain an executive Quality Dashboard tracking FPY, CoPQ, NC timeliness, and CAPA cycle times
• Lead site Quality Engineering and Inspection teams to maximize FPY and eliminate waste through MRB oversight and zero-defect initiatives
• Lead customer quality relations, complaint investigations, root-cause analyses, RMAs, and service-level reporting
• Collaborate with Supplier Quality Engineering on incoming inspection protocols, supplier non-conformances, and SCAR closure
• Lead executive Quality Management Reviews, escalate systemic risks, and drive continuous improvement
• Recruit, mentor, and develop quality engineering and compliance personnel

Director of Quality – Metals

Account Executive

• Serve as the lead point of contact for all customer account management matters
• Build and maintain strong, long-lasting client relationships
• Negotiate contracts and close agreements to maximize profits
• Develop trusted advisor relationships with key accounts, customer stakeholders, and executive sponsors
• Ensure timely and successful delivery of solutions according to customer needs and objectives
• Communicate the progress of monthly/quarterly initiatives to internal and external stakeholders
• Develop new business with existing clients and/or identify areas of improvement to meet sales quotas
• Forecast and track key account metrics, including quarterly sales results and annual forecasts
• Prepare reports on account status
• Collaborate with the sales team to identify and grow opportunities within the territory
• Assist with challenging client requests or issue escalations as needed
• Liaise with cross-functional internal teams, including Customer Service and Product Development, to improve the customer experience
• Occasional travel may be required

Director of Quality – Metals

Executive Account Manager, Medical Device Manufacturing