Quality Manager

2 weeks ago

Wolcott, Connecticut, United States Nissha Medical Technologies Full time
Nissha Medical Technologies is looking for a Quality Manager to join our Wolcott, CT. Team

The Quality Manager has overall responsibility and authority to develop, monitor, and improve the Quality Management System to ensure that the company's products and services meet or exceeds regulatory and customers' requirements.

Serves as the Quality leader to support new product development, procurement, manufacturing, and returns of products manufactured. Designated Management Representative for the Wolcott, CT. site.

ESSENTIAL FUNCTIONS AND BASIC DUTIES
(other duties as assigned) :

General:


Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.

Demonstrates knowledge and acts in accordance with NMT's Employee Guidelines and applicable quality standards as outlined in NMT's Quality Manual.

Abides by all safety and security rules set forth by the company and regulatory agencies
Regular attendance is required.

Quality System:
Responsible for maintenance and ongoing improvement of the Quality Management System.
Responsible for the establishment and tracking of Quality KPIs.
Develop short and long-range Quality Department plans and budgets.
Schedule and conduct corporate Management Reviews.
Act as the primary company interface with the FDA and MDSAP ISO 13485 Registrar.
Act as the Regulatory Affairs Officer for the company.

Management:
Responsible for selection, supervision, and performance management of department employees.
Participate in staff management training and effectively manage employees in compliance with federal and state employment laws and regulations.
Interview, hire, and train new department employees.
Facilitate ongoing training for team members to increase skill set in the department.
Conduct timely performance reviews, establish clear goals, and support learning opportunities for job skills and career growth.

Quality Control and Quality Assurance:
Implement and ensure execution of all inspection activities.

Assure that all work performed conforms to 21 CFR 820 and ISO 13485 standards and is conducted in accordance with cGMP regulations in all areas.

Oversee the resolution of customers' technical issues and complaints.
Identify and implement process improvements.
Address and implement corrective and preventive actions.
Manage the scheduling and execution of internal and external audits.

Documentation:
Responsible for the maintenance of all company documentation via the Document Control system.
Reviews, revises, and approves required documentation and procedures.

REQUIREMENTS:
BS Engineering or related field.
MBA preferred.
CQE or CMQ/OE certification preferred.
Minimum 2 years' related experience in leadership /supervisory capacity.
Minimum 8 years' experience in a Quality role.
Experience reading and understanding regulations, standards, and procedures.
Knowledge of FDA cGMP and validation requirements and practices required.
Familiarity with typical handheld and mechanical measurement equipment.
Experience with optical comparator and CMM programming preferred.
Experience reading and interpreting drawings including GD&T.
Ability to write routine reports and correspondence.
Strong attention to detail and deadlines.
Proficient computer skills with documentation related databases and Microsoft Office (Word and Excel).

The established Compensation for this position will be $90,000 to $105,000 per year (paid on a bi-weekly basis) depending on qualifications and experience.

Great benefits available including Medical, Dental, Vision, 401k, Short-Term Disability, Long-Term Disability, Basic and Voluntary Life Insurance, Paid Vacation Time, Paid Sick Leave, Educational Assistance, and more


Nissha Medical Technologies is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, gender expression, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status.

In addition, NMT will provide reasonable accommodations for qualified individuals with disabilities.
If you need assistance with completing the online application process, please call
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