Quality Assurance Manager-ManchesterConnecticut

MUST ALREADY LIVE IN OR COMMUTABLE TO MANCHESTER

Pay Rate100000-125000Other Compensation15% bonus potential

The QA Manager manages all quality systems including supplier
development, calibration, internal auditing, NCMR, CAPA, quality
engineering, production support efforts including

The QA Manager will manage complaint handling and implement compliance
training

The QA Manager ensures regulatory compliance systems are in place and
adhered

The QA Manager represents quality/regulatory for new product
development, providing statistical support as needed throughout the


The QA Manager serves as the designated Management Representative for
the

Responsibilities:

- Manage and improve quality management systems for on-going
compliance with international medical device related laws including
FDA regulations and ISO

- Ensure that NCMR, CAPA, supplier/internal audits, calibration
system, supplier development engineering, quality engineering, and
complaint handling are staffed with qualified

- Supervise 2-3 direct reports and provide resources to do their
assigned

- Support regulatory change assessments, validation protocols,
procedures and specification

- Represent Quality/Regulatory for new and existing product
improvement, manufacturing transfers, and quality plan

- Manage review and approve customer facing content including labeling
and marketing materials

- Ensure compliance with all company/business policies and procedures
as applicable

Qualifications

Requirements:

- BS in Engineering or Physical Science or

- 5 years related Quality/Regulatory experience in an ISO environment

- Regulatory, cGMP, QSR knowledge base including ISO

- Supplier Auditing Skills

- Communication skills with all levels of the organization and
customers and

- Project Management skills and ability write procedures, work
instructions, reports