The primary function of a Product Quality Assurance Analyst II is to serve as a facilitator to identify, review and assess the impact of worldwide product manufacturing, quality, regulatory or safety issues that arise in complaint investigations, manufacturing deviations, trend analysis or other non-conformities related to products sold by ADC.
This includes but is not limited to:
Reviewing customer complaints, exception reports, manufacturing deviations, investigation reports and regulatory requirements against existing historical analysis to identify new issues.
Facilitate cross functional meetings to make recommendations on the need for product controls and or risk evaluations.
Initiating and facilitating the product control processes.
Drafting, reviewing, and issuing stop shipments, quality holds and stop build orders and dispositions in alignment with the exception report processes as applicable.
Initiating and facilitating the risk evaluation processes.
Drafting, reviewing, and closing risk evaluations with inputs from cross functional teams.
Preparing and participating or facilitating in regular meetings with Senior Level management.
Coordinating slides, meeting minutes, and action items.
Participate in design reviews as required providing technical inputs and historical information for product controls.
Draft, review and implement process improvements through procedures and work instructions.
Coordinate and execute field actions as they arise, from facilitating the meetings, to finalizing documents.
Working across the organization with multiple levels of management to ensure field actions are executed in a timely manner.
Provides direction to junior staff on daily activities.
Provides recommendations for product control, risk assessments and field actions.
Escalate issues to Management and serve as delegate for management as appropriate in audit settings.
Communicate directly to Customer Service, Sales and Marketing, Regulatory, Medical Affairs and other affected areas of the business for new issues as well as product releases via the advisory notice process.
Identify, write exception reports into the nonconformance system as appropriate in a timely manner.
Responsible for adhering to quality policies.
Maintaining original files in PQA archival system.
Makes recommendations and suggestions for decisions to cross functional teams and management as appropriate.
Communicates directly with Sr. management when appropriate.
Leads others in the completion of project tasks.
Provides guidance and daily supervision for junior staff, and removes barriers impeding the progress of projects.
A bachelor’s degree with a minimum of six (6) years’ experience or equivalent with a minimum of seven (7) years of related experience in a medical device or pharmaceutical field in lieu of a bachelor’s degree is acceptable. Strong working knowledge of FDA Code of Federal Regulations as it applies to medical device manufacturing, including cGMP, ISO14971, as well as complaint handling systems. Prior experience in the medical device industry and or quality systems are required. Proven track record of managing projects from initiation to completion in a timely manner. Strong technical writing skills and excellent oral and written communication skills