Perform all acceptance activities (incoming inspection, final release inspection, in-process
inspections, first article inspections, etc.) assuring that these activities are properly performed and
• Assure that quality activities performed by other functions (e.g., in-process or final inspections
performed by manufacturing, equipment and process validations, etc.) follow approved procedures
and are performed by adequately trained personnel.
• Run reports, locate and organize daily work, as applicable.
• Drive quality improvements using solid engineering tools and report on status as necessary. Evaluate
new inspection equipment, techniques and methods.
• Oversee local calibration system and ensure all instruments, materials, written procedures, etc.,
used in inspection process are current.
• Assure that the quality system is designed and implemented such that certifications will be
maintained; assure that proper communication with senior management is maintained.
• Assist in assuring that Quality System documentation is kept up to date; control changes to the
Quality Manual; review/approve changes to Operating Procedures; review and approve Risk
Assessment Reports, Essential Requirements Checklists, Design Requirements documents, Design
• Ensure equipment, software, and process validation activities are implemented per the quality
management system requirements.
• Facilitate the local implementation of global UDI requirements for the products within the
applicable compliance timeframe.
• Lead external regulatory agency, Notified Body or customer audits for the facility.
• Support Corrective and Preventive Action (CAPA) System • Support supplier quality audits and serve
as Internal Audit Team member
• Ensure standards are set for control of raw material.
Maintain up-to-date professional and technical knowledge and ensure compliance with local
regulations and standards including compliance with all applicable Food & Drug
• Administration (FDA) and European Union Medical Device Regulation (MDR) as well as other
applicable global regulatory requirements (i.e. U.S. EPA) that impact the devices produced by
• Teach, govern, and lead efforts that proactively ensure Quality Assurance for Banyan USAs
• Complete other responsibilities, as assigned.
• A bachelor’s degree in technical field (Quality Engineering, Mechanical or Biomedical Engineering)
preferred. Equivalent work experience accepted.
• At least 3 to 5 years of experience in Quality Assurance/Control. Medical device/FDA experience
• Knowledge of process and/or product validation concepts and techniques.
• Excellent team player.
• Demonstrates skill at multi-tasking and resourcefulness. Ability to efficiently participate
simultaneously in multiple projects.
• Good presentation and training skills for both internal and external audiences.
• Strong analysis & problem-solving skills.
• Strong written and oral communication skills, exceptional listening skills.
• Computer literate (especially spreadsheets, databases, and presentation software) and the ability to
use communications tools, such as email, web-conferencing systems, etc.
Contract Specialties Group is an Equal Opportunity Employer. We consider applicants without regard to race, color, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, or membership in any other group protected by federal, state or local law.
Job ID: 17511