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Job Description:
Adecco Employment Services is the global leader in employment and HR services, connecting people to jobs and jobs to people through its network of more than 6000 offices in 71 countries and territories around the world. We are currently seeking a Mechanical Designer for our client a medical company in Mahwah, NJ. Our client a Global Leader in the Medical Device industry is currently seeking a Manager of Quality Assurance and Regulatory Compliance.
. Manage the division's internal and external audit functions to ensure compliance to regulatory and statutory requirements. Coordinate activities of Third Party visits (Notified Body, FDA). Coordinate Management Review Activities. Ensure overall QMS system compliance with applicable regulatory and statutory requirements.
ESSENTIAL DUTIES & RESPONSIBILITIES:
. Manage the internal and external audit functions to ensure compliance to regulatory and statutory requirements
. Coordinate activities of Third Party visits (Notified Body, FDA) and associated corrective action activities
. Coordinate Management Review activities
. Perform annual performance reviews and recommend appropriate salary action
. Ensure overall QMS system compliance with applicable regulatory and statutory requirements
. Perform internal quality assurance audits to 21CFR 820, ISO 9001:2000, ISO 13485:2003, 93/42/EEC and other applicable Standards to ensure corporate and regulatory compliance
. Ensure effective closure, by working with auditees to ensure comprehension, development, and execution of corrective/preventive action with regards to any nonconformities cited during audits
. Develop and conduct effective training programs on related QA topics
. Conduct and support benchmarking activities
. Identify areas of opportunity and support continual improvement of the Quality Management System
. Identify, develop, and report QMS metrics
. Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of division's continual improvement initiatives
Job Experience:
Must have prior experience in the Medical Device Industry as well as:
Bachelor's Degree in scientific or other relevant field;
. Master's Degree or equivalent additional coursework preferred
. Internal or lead auditor certification (CQA/CQE)
Demonstrated experience in developing quality management systems; design and development of training programs/courses; lean documentation; and Six Sigma methodology
. Demonstrated auditing experience in medical device or other regulated manufacturing environment
. Applied understanding of CGMPs, ISO 9001, ISO 13485, and CMDR
. Demonstrated ability to effectively advocate a strategic quality systems approach and lead the organization to compliance
. Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies
. Demonstrated leadership ability and experience
. Demonstrated project management experience
. Demonstrated PC proficiency
. Demonstrated organizational and written/verbal communication skills
. Demonstrated ability to self-motivate
. Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams
. Demonstrated ability to prioritize tasks in a deadline-driven environment
Minimum Education Required: Bachelor
Years of Experience Required: More than 5 years
Expected Travel Time: None
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