Maintains the Corrective and Preventive Action (CAPA) and Non-Conforming Product Systems. Responsible for overseeing and direction of the 1 Quality System Coordinator.
Primary Responsibilities
Directs activities to resolve all internal/external complaints in the Oliver Healthcare Packaging Grand Rapids facility. This will be done by providing appropriate documentation, risk assessment, routing, corrective and preventive action evaluations, letter preparation, problem solving assistance and FMEA assessments.
Works with the Quality System Coordinator to ensure they have the necessary support or backup related to the functions of that position.
Participates in Customer audits and ISO registrar QMS audits and provides support for resolving resulting action items.
Provides assistance to teams in resolving quality corrective actions.
Prepares quality alerts, customer information or any relevant information for posting in the production Directs activities to ensure this information is routinely rotated and other postings are included to maintain interest.
Actively engages with other departments to support complaint investigations; lead investigations, observe production activities, interview Subject Matter Experts, etc.
Provides back up functions for the Quality Manager when requested.
SUPERVISORY RESPONSIBILITIES:
Manages one employee in this segment of the Quality Department. Responsible for the overall direction, coordination, and evaluation of this segment. 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.
Basic Qualifications
Education and/or Experience

• Bachelor’s degree or four years related experience and/or training; or equivalent combination of education and experience.

Preferred Qualifications

• Strong PC skills, including knowledge and application of spreadsheet, word processing and graphical analysis software is highly desired.
• Some background in Total Quality Management (TQM), FDA Good Manufacturing Practice (GMP), and ISO 13485 concepts is desired.

Working Conditions
Prolonged periods of sitting at a desk and working on a computer.
Must be comfortable engaging within a production environment.
Must be able to lift up to 10lbs
Special Requirements
Ability to travel (US and internationally)
Ability to work evenings and/or weekends