Quality Control Supervisor

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Adhere to the Company's Quality Management System to ensure compliance with applicable regulatory requirements.
• Manage daily resource utility and production workflow to ensure all daily production requirements are being met
• Develop, coordinate, and enforce systems, policies, procedures, and productivity standards for overall quality inspections
• Manage overall inspection methodology, including but not limited to equipment selection, inspection plans, SOP's, etc.
• Support the transfer of new products and processes from Engineering to Production - i.e. development and implementation of inspection methodology
• Oversee the overall calibration system for all equipment, gauging, instruments, etc.
• Track non-conforming products and lead material review board (MRB) efforts
• Support validation activities to meet manufacturing needs
• Evaluate the impact of process and equipment changes on product quality conformance
• Identify and drive continuous improvement opportunities related to product and process quality
• Manage the review of completed device history records and the transfer of product out of Quality Control
• Manage the training program for the inspection team - i.e. inspection methodology and standard practices
• Provide technical guidance to the inspection team as needed
• Provide ongoing communication and regular status updates to senior management team
• Interface and collaborate with other departments, outside vendors, stakeholders, etc.
• Perform other duties as required

SUPERVISORY RESPONSIBILITIES

Direct Reports: Yes N/A

• Monitor team productivity and provide constructive feedback
• Supervise team workflow and align performance expectations with company goals

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Proficient in blueprint reading (GD&T)
• Proficient skill with precision measuring instruments (e.g. micrometers, calipers, gauges, optical comparators, etc.)
• Must be flexible and able to adapt to change
• Strong written and verbal communication skills
• Must be able to exercise independent judgment and discretion
• Communicates and works well with employees of all positions
• Computer literacy with standard software applications

EDUCATION AND/OR EXPERIENCE

• High school diploma required
• Bachelor's degree preferred
• 5+ years of experience in a medical device manufacturing environment

CERTIFICATES, LICENSES, REGISTRATIONS

• ASQ certification preferred (e.g. Quality Manager, Engineer, Auditor, etc.)

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The work environment is an industrial setting dedicated to the production and assembly of medical devices that utilizes machinery, equipment, and specialized processes to transform raw materials into finished products. The work environment also includes a typical office setting.
• This position is based onsite and requires regular in-person attendance at the company's facility.

PHYSICAL DEMANDS