Technical support for and final review and approval of customer complaint investigations
Support new product development
Establish and maintain Quality Management System procedures Facilitate the execution of Risk Management activities.
Identify statistically based sampling plans for inspections and validations
Support validations for new and existing products, processes and equipment.
Ensure compliance with cGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
Participate in FDA inspections, ISO Certification and surveillance audits and customer audits
Identify and implement opportunities for continuous improvement.
Interact and coordinate activities with other departments, external vendors and customers
Assist or lead in the identification and implementation of CAPA
Aid in the implementation SPC control system with Manufacturing and Quality Control
Completes internal quality system audits
Provides support necessary for supplier controls, including but not limited to: supplier audits
Participates in Post-Market Surveillance (PMS) activities as required
Collection and reporting of metrics and data as required
Performs other Quality System related duties as required.
BS degree in Engineering, Science (Biology, Chemistry, Physics, etc.), or Math (Statistics)
Minimum of three years’ experience in Engineering
Knowledge of statistical sampling and analysis
Good organizational, writing and verbal communication skills
Familiar with the MS Office Suite, including Microsoft Visio and
Project Knowledge of quality system standards, and other national and international regulations and standards
Experience working in regulated industry (Medical Device, Pharma, Aerospace) a plus
Must be able to read and write in English. Must be able to demonstrate comprehension of written English by successfully completing unassisted written tests, including, but not limited to, Work Instructions and Standard Operating Procedures.
Must be able to observe company policies and safety procedures at all times.
Must be able to give and welcome constructive feedback; contribute to building a positive team spirit.
Must be able to treat others with respect; work with integrity and ethically; uphold organizational values.