The Quality Specialist will work directly with the Production and Engineering teams to ensure products conform to quality standards and establish compliance with the quality system. The Quality Specialist is also responsible for maintaining a strong, collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
Responsibilities• Coordinates CAPA investigations and implements corrective/preventive actions• Supports manufacturing by resolving manufacturing and supplier issues• Leads periodic Failure Review Board meetings• Conducts non-conformance risk assessments• Ensures product conformity to internal and external quality requirements• Documentation, root cause analysis investigation, record management• Supports internal, external, and supplier audits as needed• Perform other job-related duties assigned• Train, coach, and guide employees on procedures.
Education/Experience Requirements• Two (2) year Applied Science Degree and/or equivalent work experience required• Experience working in the medical device or other regulated industry preferred• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements preferred• Understanding of Risk Management practices, including FMEA• Strong understanding of statistical techniques• Strong understanding of Root Cause Analysis techniques• Experience with Process Validations preferred• Experience with internal and/or external audits preferred• Hands on experience with electronics preferred
Pay Rate: Salary starting at $41,600
Shift Available: First
ESSENTIAL DUTIES• Provide tools, fixtures, molds, auxiliary equipment to CCS personnel as needed in a timely manner.• Assist CCS personnel in setting up tools, fixtures and auxiliary equipment on the floor; prepare, inspect and verify tool readiness for production• Read and understand set-up requirements in the routing.• Maintain physical and functional condition of tools, fixtures, molds and auxiliary equipment on the floor.• Able to perform minor mechanical adjustments or troubleshoot equipment when needed.• Coordinate with maintenance department when equipment needs repair.• Coordinate with quality department in regards to calibration of tools, fixtures and equipment.• Assist in cell and/or equipment layout.• Assist in performing equipment or process validation when required.• Complete all required routine paperwork as necessary• Evaluate preventive maintenance and process for conformance to quality and production standards• Maintain clean work station throughout each shift• Understand and follow quality-related standards and documentation• Determine proper disposition of non-conforming product or procedure as directed• Maintain satisfactory attendance record as required for this position; willing to work overtime as needed
QUALIFICATIONS• Proficient mechanical aptitude with some industrial experience required; high school diploma with vocational training or apprenticeship in mechanics preferred• Preventive maintenance and/or mechanical repair experience with small tools or machinery preferred• Must be able to operate computers used in this department• Must be able to negotiate multiple tasks concurrently and work with the pressure of deadlines• Must have proficient communication, organization & follow-up skills• Must be comfortable with on-the-job training and cross-training• Must be able to work as a team player as well as independently, exploring and sharing ways to improve efficiency• Must be able to read, comprehend and carry out simple, but detailed instructions, both written and oral• Must be detail-oriented: accurate, consistent, thorough, neat, able to recognize mold/equipment damage/flaws, punctual• Must be able to maintain a satisfactory attendance record and work overtime including weekends if required• Must be proficient in linear measurement, e.g. use of ruler
Pay Rate: Starting at $17.50
Shift Available: First