POSITION SUMMARY: Responsible for implementation of Quality Systems elements in accordance with FDA Quality Systems Regulations and ISO 13485 standards. Responsible for providing direct support and oversight of product and manufacturing engineering activities including manufacturing process capability and supply chain quality management.
PRINCIPAL JOB DUTIES & RESPONSIBILITIES:
Perform as an active member of product design and development teams, participating in project meetings, design reviews, risk management, and other activities as required by the Design Control Process.
Participates on Build-4-Me Product Development and Manufacturing team to assure that all quality and regulatory issues are addressed for customer requested modification.
Provides Quality review and authorization for documentation changes to engineering prints, Quality Plans, manufacturing work instructions, process sheets and inspection plans. Provides Quality review for product design changes. Carry out process validations, equipment qualifications and assist with material certification as necessary from the suppliers.
Execute and administer CAPA (Corrective and Preventive Action) tools as required, both internally and externally to bring about the desired positive changes and continuous improvements.
Assist in defining/maintaining Quality metrics for internal and external reporting. Perform trend analysis as required.
Review Design History Files for accuracy and compliance to internal and FDA requirements.
Revise Quality System and Manufacturing procedures as required.
Represent Quality on various teams, including ISO or FDA Audits/Inspections providing data analysis as needed.
Write and submit NCMR’s and create Deviations or initiate and participate in control of non-conforming materials.
Participate on Internal Quality Audit Team.
Visit and audit suppliers as necessary from time to time.
Other special projects/assignments as designated by the Quality Manager.
Qualication:
Qualifications
REQUIRED SKILLS, KNOWLEDGE AND EXPERIENCE:
Bachelor of Science in an engineering discipline or equivalent experience. Mechanical, Manufacturing, Process or Quality Engineering Degree a plus.
Two years of experience in manufacturing or quality environment required. Medical devices or wheelchair/mobility products experience a strong plus.
Knowledge of computer database systems, Microsoft applications, PC, and various software programs required.
Strong aptitude for problem solving, root cause analyses, and an understanding of dynamic mechanical assemblies desired. Process/product validation experience a plus.
Knowledge of ISO 13485, 21 CFR 820, and ISO 14971 preferred.
Certified Six Sigma Green Belt Certification a plus.
Experience with Quality Risk Assessment tools such as HARMs, FMEA, MRB, CAPA, required.
Capable to present data (presentations) to management teams and train co-workers as needed.
Must have ability to properly interpret Engineering drawings and clearly present that information to others.
Ability to travel to other facilities to support quality audits and/or issues is required.
Able to frequently multi-task and assist QA Manager or others in QA with their job-related duties.
