Job Title:  Quality Lead

This a Union role and must join the union after 90 day probationary period. This is a full-time position on 1st shift. The work hours are Monday-Friday 7 a.m. to 3:30 p.m. 

SUMMARY OF POSITION:   Point of contact for all cell-related issues.  Determines the effective use of assigned personnel.  Supervises and performs in-process and finished good inspection on all products, approves them for shipping, and verifies package and labeling procedures are followed, as applicable.  

ESSENTIAL FUNCTIONS: 

• Responsible for directing work activities of work cell quality inspectors to optimize throughput and inspection of all scheduled production work orders within expected timeframes including the use of overtime as approved by management.

• Provide leadership, guidance, and training to personnel in respective cells to ensure quality and paperwork is completed properly.

• Verify that all production procedures have been followed & records are maintained correctly.
• Assist in resolution & disposition of non-conforming materials found in inspections performed (i.e. IDR’s, receiving, in-process, final).
• Assist in development of additional quality systems to improve current systems (i.e. work center metrics).
• Assist in internal quality audits. 
• Inspect at various work centers for process compliance.
• Monitor receipt & verify complaint, condition and quantity of products returned from suppliers and customers under the applicable procedure.   
• Provide new hire and ongoing training to ensure requirements are met and enable cell quality inspectors to increase their knowledge and skills.

• Assists or provide input to Quality Manager in employee development, corrective actions, reviews and disciplinary actions, as required. 
• Practical implementation of systems and procedures for meeting current ISO and FDA requirements.
• Responsible for recommendation of, and involvement in, methods and process improvements. 
• Ensure that all procedures and policies are followed, and safety precautions are taken to reduce risk and injuries.
• Ensure preventive maintenance and upkeep of equipment.
• Comply with ISO policies and procedures.
• Ensure cell reporting is completed and submitted in a timely manner.
• Support quality improvement and cost savings initiatives, as required.
• Be able to meet the visual acuity requirements (shades of color and color blindness).
• Be able to meet the requirements of the vision screening test (eye chart).
• Other duties as assigned.

OCCASIONAL DUTIES: Assist receiving inspections on products from outside sources.  Assist with first piece inspections.  Assist shipping with the preparation of outbound freight.

EXPERIENCE / EDUCATION: High School Diploma or equivalent required.  Post-secondary education a plus.  Working knowledge of statistical analysis & methods required.  Previous experience of 3-5 years in manufacturing environment.  Attainment or future attainment of ASQ CQT certification.  Excellent knowledge of drawings & parts manufactured from drawings.  Working knowledge of current ISO and FDA requirements.  Previous orthopedic experience preferred.  Previous supervision or leadership experience required.

SKILLS: 

• Excellent organizational skills and attention to detail required.
• Excellent follow-up skills required.
• Ability to juggle multiple tasks with minimal supervision, and multi-task in a fast-paced environment.
• Leadership skills and ability to influence others.
• Skilled in dealing with all levels of staff, production through management.
• Ability to independently solve problems and make recommendations.
• Proactive approach in completing tasks and projects. Strong project management skills required.
• Strong computer skills required.  Previous experience with an MRP system preferred.  Word/Excel/PowerPoint expertise a plus.
• Ability to work and contribute in a team oriented, continuous improvement, manufacturing environment.
• The ability to use test equipment such as micrometers, calipers, gage blocks, pin gages, optical comparators, and coordinate measuring machines.
• Expertise in geometric dimensioning and tolerancing (GD&T) at an inspection level (at a minimum) is required.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:   The physical demands and work environment characteristics described here are representative of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical demands: While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch, or crawl; talk or hear; taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

• Work environment: Work performed in a production environment. While performing the duties of this job, the employee is exposed to weather conditions prevalent at the time (for Maintenance & Receiving only). The noise level in the work environment is usually moderate to high, in some areas.