Sr. Quality Manager

The Senior Quality Manager is the leader and technical head for all quality activities for the assigned PerkinElmer site(s). As Senior Quality Manager of an ISO 13485 certified / FDA registered /QSR compliant manufacturing facility of a regulated in vitro diagnostic devices and research use only products, this position is responsible for evolving and maintaining a quality system compliant with the applicable medical device regulations. The position will be involved in the review of manufacturing issues and expected to recommend solutions to reduce the frequency of product quality issues. Position reports to the Director of Compliance and Quality for our Diagnostics business unit.

Duties and Responsibilities:
Partner with Diagnostics and LST Senior Management and local Site Management to establish, implement and maintain a compliant Quality Management System necessary to successfully produce and support the appropriate class Medical Device products and services (to include, but not be limited to design control, document control, production and process control, nonconformance management, CAPAs, labeling, customer complaints, storage, and distribution).

• Ensure a comprehensive and complete Quality Management System is established and implemented to be compliant with applicable regulatory requirements (FDA, ISO 13485, CMDR, etc.)
• Achieve and maintain necessary site /quality system registrations and certifications for the established Quality System as deemed necessary by the business
• Function as the Management Representative and prepare for and participate in FDA, ISO and Customer audits as the main contact
• Manage routine QMR process, participate in MOR process, and support Diagnostics BE QMR process
• Coordinate with Regulatory to support domestic and international product registrations.
• Management and oversight of the corrective and preventive action process, analyze data from Nonconformities, Deviations, CAPA and maintain all data
• Management and oversight of the complaint handling process to ensure timely analysis, investigation and closure of complaints as well as reporting MDRs and Adverse Events as necessary.
• Collect and analyze data required by regulatory agencies and by internal requirements
• Ensure appropriate training is established and implemented for all companywide Standard Operating Procedures as well as all site specific Standard Operating Procedures and Work Instructions
• Oversight responsibilities in association with final product release ensuring they conform to regulatory, customer and company standards.
• Manage the internal audit schedule and process; maintain all records of internal audits
• Respond to and maintain oversight of audit finding remediation
• As needed, apply continuous improvement principles for system optimization
• Monitor performance and progress against documented objectives
• Promote awareness of regulatory and customer requirements throughout the organization
• Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products
• Develops the budget and monitors expenditures.
• Selects, develops and evaluates personnel to ensure the efficient operation of the function.
• Supervises technical documentation writers, including coordinating needs across product families.
• Oversees audits of raw material vendors and manufacturing documentation for updated filing.
• Lead investigations and resolve potential product quality issues.
• Makes recommendations for corrective action necessary to ensure conformity with quality specifications
• Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.