Sr. Supervisor, Quality Control
Position Overview
Direct, coordinate, and improve product inspection activities using knowledge of product technology, quality specifications and procedures. Job duties:
- Responsible for planning and managing the Quality Control function including in-process inspections, and final assembly inspections.
- Direct the workflow of the Quality Control group and report on the status and results of inspection and test activities.
- Manage QC department and overall expectations pertaining to setting accurate schedules and allocating resources.
- Ensure delivery against QC department goals and objectives, i.e. meeting commitments and coordinating overall inspection schedule.
- Responsible for the execution, maintenance, and periodic review of inspection process and procedures.
- Develop metrics to identify and prioritize activities pertinent to process control, risk reduction, and cost improvement.
- Support the execution of improvement and cost saving projects and compliance remediation activities, ensuring proper leadership, interaction with cross-functional team, project management capability and accurate reporting.
- Directly supervise QC staff including coaching and developing to enable maximum performance and individual associate growth, providing regular performance review and feedback.
- Manage QC staff to ensure that inspection activities are compliant to documented procedures.
- Support technical aspects of the inspection process, including method troubleshooting and statistics.
- Ensure nonconforming and/or suspect material is appropriately documented, segregated, and reported to facilitate effective disposition.
- Perform other duties as assigned.
- Bachelor’s degree or equivalent combination of education and experience in the medical device industry.
- Minimum 4 years of quality control experience.
- Minimum 1 year of recent supervisory experience for medical device manufacturing.
- Hands-on experience with process improvement projects.
- Technical expertise to drive troubleshooting and failure investigations.
- Use of microscope and other hand measurement tools required to perform inspections.
- Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.
- Competent at inspection techniques; solid understanding of technical documentation including mechanical drawings.
- Good written and verbal communications.
- Ability to read technical documentation.
- Experience working in controlled environments (clean rooms).
- Good interpersonal skills.
- Knowledge of Quality Systems for medical device manufacturing and requirements for inspection and testing i.e. FDA QSR and ISO 13485.
- Ability to manage and prioritize multiple projects and deliverables while clearly communicating status and identifying obstacles.