Braxton30 years in quality management leading internal/external audits

Relevant Skills

Organizing and leading internal and external audits, Designing a data-driven, risk-based rationale, Overhauling the risk management process

Expertise Summary

Braxton is an accomplished and experienced Sr. Quality Manager with 30+ years of experience within the medical device quality manufacturing industry and regulatory field.
- He has experience working closely with domestic and international bodies, as well as organizing and successfully leading internal and external audits.
Braxton possesses multifaceted management skills including the following: working with customers in a casual and critical situation regarding product complaints, quality assurance, project management, program development, training experience, customer service, and a successful track record conducting internal and external FDA, CDC, MDD, EU MDR, Health Canada, DOD, and ISO audits.
Braxton directed all functional areas across the entirety of the quality department, including the hiring and realigning of staff personnel and improving support of the department and organization’s mission and KPIs.
Braxton spearheaded a healthcare company’s transformation from the EU MDD to the EU Medical Devise Regulations.
- He spearheaded a TUV ISO 13485 Surveillance Audit, which included the 2016 upgrade, resulting in zero nonconformance recorded.
- Additionally, he spearheaded the Medical Device Single Audit Program (MDSAP), a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s Quality Management System that satisfies the requirements of multiple regulatory jurisdictions, including the FDA.
Braxton managed design history file and risk management file remediation, quality system improvements to support a pre-market approval application, and FDA PMA pre-inspection on several devices throughout his career.
- He also transformed the organizational perspective on risk management by overhauling the risk management process in compliance with ISO 14971, and utilized the tools and philosophy to leverage risk across the business.
- Braxton optimized and reduced the overall supply chain risk by establishing the supplier quality function and its related infrastructure.
- He developed a strategy to establish the quality department, formulating a resource plan, and identifying responsibilities and department’s short term and long term priorities with a focus on FDA readiness and MDD & EU MDR compliance.
Braxton devised and implemented both a 90-day plan and a comprehensive learning plan to accelerate transition and integration.
- He created a diversified project plan identifying regulatory and technical requirements for the transfer of a key product line to an alternate contract manufacturer.
- He also designed a data-driven, risk-based rationale to resolve a significant compliance gap and defend inventory.

LOOKING FOR:

Permanent

YEARS OF EXPERIENCE:

30

EXPERTISE:

Quality assurance, project management, program development, and training

Braxton30 years in quality management leading internal/external audits

Relevant Skills

Expertise Summary

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