Director of Quality and Compliance, Medical Devices
Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20369-BZ1
Compensation : 120000.00 - 160000.00 USD/YEAR
Start Date : 11/13/2020
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Engineering
Job Description :
- Permanent position for a Director of Quality Assurance and Compliance to lead and have hands-on responsibility for setting up and maintaining a Quality Management System for a medical device manufacturing organization.
- Oversee quality assurance functions, quality control functions, quality systems compliance and managing any clinical studies.
- Responsible for developing and maintaining the Quality System compliant with ISO 13485, FDA Quality System Guidelines, CE marking and any company strategic partner quality system requirements.
- Develop the quality plan, oversee the Management Review periodic meetings and drive the quality message throughout the company.
- Manage the MRB and CAPA functions.
- Participate and interface with the research and development function on new product projects and Design Transfer into manufacturing.
- Participate with manufacturing in the development of production quality control plans and serve as the independent quality assurance function to ensure compliance to quality systems.
- Oversee the quality control function with "dotted-line" engineering and product priorities assistance from manufacturing.
- Assist with supplier management with focus on approving suppliers.
- Manage the control and release of instructions, procedures, drawings, records, and other quality documents.
- Manage the identification, collection, indexing, disposition, and amendment of quality documents in either a manual and/or electronic system.
- Oversee system required to ensure training requirements met.
- Manage post-market surveillance including customer complaints, regulatory medical device reporting and advisory/recall notices.
- Responsible for departmental operating budget plan development and resource oversight.
- If required, develop and administer system for clinical studies in support of regulatory filings.
Required Qualifications :
- BS or MS in Engineering, Science or Biomedical field
- Experience with ISO 13485 and US FDA Quality System required.
- Experience with validation DQ, IQ, OQ, PQ requirements.
- Knowledge of the device branch of the FDA and FDA regulations.
- General knowledge of orthopedic medical device systems and their intended function.
- Minimum 5 years in managing all aspects of quality systems including audits.
- ISO 13485 and CAPA training preferred.
Contact: Bill Zukowsky