Leads multiple quality assurance projects to enhance the company’s compliance to quality system requirements. Incorporates the relevant quality system requirements into the company’s procedures and practices.
Works closely with Manufacturing, R&D, Regulatory and other Quality Assurance areas to improve adherence to regulations and internal procedures.
Manages internal and third-party audit program. Performs gap assessment on new quality system regulations and communicates the gaps to impacted associates.
Conducts and leads internal investigation of third-party audit findings. Prepares compliance status reports, metrics, trends findings, and identifies and supports improvement initiatives.
Manages overall internal audit program, including preparing audit schedule, conducting audit (process, products, and quality system), preparing audit reports, and reviewing documents to address audit findings.
Manages activities to support third-party audits.
Manages CAPA and Field Corrective Action program.
Establishes, develops, and performs quality compliance training.
Prepares the required metrics, dashboards, and reports for Quality Review.
Supports and coordinates document change control activities including translation, training compilation, and record management.
Keeps abreast with all applicable regulations, performs and / or coordinates gap assessment of new quality system regulations, and prepares plan for implementing the new regulations as related to changes in Quality System.
Collaborates with various functions to implement new regulations.
Conducts and directs investigation of quality compliance issues and assists in preparing corrective actions related to third party audit findings.
Prepares quality compliance status reports, trend findings, and escalates critical issues that warrant further actions.
Creates and / or revises procedures to ensure compliance or drive improvement.
Performs other duties and responsibilities as assigned
Bachelor’s Degree required or equivalent experience.
A minimum of eight years of quality compliance related experience in the medical device industry including combination products, and 2 years of supervisory experience.
Knowledgeable in 21CFR 820, 21 CFR 803, 21CFR 806, 21CFR Part 4, ISO13485, ISO14971, MDD, CMDCAS, MDSAP.
Must have a valid quality audit or certification by a recognized organization (i.e., ASQ Certified Quality Auditor, Exemplar Global-certified ISO13485 lead auditor training).
Experience in MDSAP implementation preferred.
Project Management Professional certification preferred.
Successful experience working independently, effectively and confidently in a team environment.
Ability to communicate effectively and partner with associates at various levels within the organization.
Proficient with MS Word, Excel, PowerPoint, Visio and Outlook.