Wallingford, United States
about 2 months ago
Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.
We are currently seeking a Director of Quality in Wallingford, CT.
Position Summary and Special Duties:
As a (an) Director of Quality your day-to-day duties will consist of and may not be limited to:
The Director of Quality directs and coordinates all quality assurance and quality control activities for our Simple Plex automated immunoassay business. This individual will be responsible for providing leadership for day-to-day operations of quality assurance, document control and quality control. This individual will lead a Quality team that certifies the products delivered to customers which meets our stringent quality standards. This individual will ensure our Simple Plex products meet the requirements of the Quality Management System (QMS) and applicable regulatory requirements as needed. The manufacturing site is moving to ISO 13485 certification. The right leader will establish, implement, and maintain the QMS that is complaint with ISO 13485 and ISO 9001 standards for the site.
- Establish, implement, and maintain the Quality Management System (QMS) that is compliant with ISO 13485 and ISO 9001 standards. Maintain site-specific ISO certifications.
- Serve as Management Representative for the site as outlined in ISO standards and QSR Regulation Part 820.20.
- Works cross functionally with key department heads in R&D, Supply Chain, Process Development, Manufacturing and Regulatory Compliance ensure alignment and compliance with the QMS, support assessment of compliance, and define metrics to determine appropriate actions to be taken to achieve regulatory and quality compliance.
- Oversee QA review and ensure products are designed, manufactured, and released within the guidelines of the QMS and relevant regulatory agencies.
- Implementing methods to inspect, test and evaluate products and production equipment.
- Oversee use and management of the Document Control system. Ensures that effective documents are controlled and distributed properly.
- Ensure timely closure of all non-conformances, failure investigation reports and corrective/preventive actions (CAPA) and in accordance with the established guidelines and database systems.
- Ensures all product complaints and investigations are appropriately investigated and closed.
- Coordinate internal audits of company departments and vendors’ management to ensure product quality, consistency, and compliance to regulations.
- Analyze and present related reports, data and Key Performance Indicators for management and executive review as requested. Monitor, communicate and act on any trends emerging.
- Conduct initial new employee training of the QMS in accordance the established Training program.
- Acts as a support for customer and regulatory audits.
- Provides training and coaching to personnel within and outside the Quality departments.
Education and Experience:
- Bachelor’s degree in a biological-based science and minimum of 3-5 years of leadership experience in Quality Assurance, Quality Control, or combined experience, including GMP in a Life Science business.
- Working knowledge of Quality systems, ISO, GMP/FDA processes, requirements, etc.
- 3-5 years hands on regulatory affairs 510K/EU Standards.
- Overseeing 5 managers over group of 20 people.
- Demonstrated verbal, written and interpersonal communication skills.
- Ability to show initiative and to perform in a multi-task environment.
- Detail oriented with good organizational and record keeping skills.
- Able to be flexible and adaptable when needs and priorities change.
- Duration: Direct Hire permanent with bonus.
- Location: Wallingford, CT. and oversees San Jose, CA. Site.
- Salary: Salary plus bonus plus stock plan.
- Benefits: Yes
- Start time 7:30 -8:30 – to 4:30 -5:30 start is flexible.
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.