Quality Engineer

Zavation Medical Products•Flowood, MS

26d

About The Position

The Quality Engineer supports manufacturing and quality departments while ensuring compliance with industry and regulatory standards. The role includes supervising quality technicians as needed; managing gaging, calibration, inspection equipment, equipment records, non-conforming materials, and shop-floor quality documentation; and overseeing CMM operation. The Quality Engineer also supports customer complaints, PFMEA activities, audits, facility inspections, procedure development, and validation activities, while following applicable safety protocols and Good Manufacturing Practices (GMP). The position requires relevant quality experience, attention to detail, and commitment to maintaining required records. The employee works in an office environment with prolonged periods of sitting and computer use. Minimal travel is expected. Physical demands include regularly sitting and using hands to handle or feel objects, tools, or controls; frequently talking and hearing; occasionally standing, walking, reaching, and lifting or moving up to 10 pounds. Clear written and verbal communication and the ability to see clearly at close and intermediate distances are required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Requirements

Bachelor’s degree in a technical discipline or 10 years of experience working in quality control or quality assurance in a manufacturing environment.
Experience programming and operating a CMM and vision-style measuring systems.
Experience supporting manufacturing and quality.
Excellent command of ISO and FDA requirements for medical product manufacturing.
Ability to communicate effectively with direct reports.
Good project management and report-writing skills.
Good oral and written communication skills.
Ability to manage multiple projects simultaneously.
Experience attending ISO certification audits or FDA inspections to answer questions concerning calibration and inspection.
Ability to work independently and adhere to timelines.
Ability to sit regularly and use hands to handle or feel objects, tools, or controls; talk and hear frequently; and stand, walk, and reach occasionally.
Ability to lift and/or move up to 10 pounds occasionally.
Ability to see clearly at close and intermediate distances and adjust focus as needed.
Ability to work in an office environment with prolonged periods of sitting and computer use.

Responsibilities

Supervise quality technicians as needed to ensure quality and regulatory requirements are met and customer needs are satisfied.
Manage gaging, including calibration activities.
Manage non-conforming materials for the shop floor and ensure requirements are met.
Aid in processing customer complaints.
Maintain document control for shop-floor quality documentation.
Develop and maintain equipment files, including assigning asset numbers.
Manage CMM operation, including programming, ordering consumables, maintenance, and training operators.
Participate as a quality representative in PFMEA activities.
Perform routine maintenance on inspection equipment.
Conduct routine facility inspections to ensure quality and regulatory requirements are met and report results to management.
Follow and enforce Good Manufacturing Practices (GMP) and other relevant industry regulations and standards.
Aid in developing work instructions and procedures.
Assist with internal and external audits as needed.
Comply with safety procedures and protocols.
Identify and report safety hazards or concerns.
Complete and/or participate in validation activities.