Find & Apply For Quality Control Systems Manager Jobs in Fairfield, New Jersey

Job Overview:

Responsible for leading and maintaining an ISO 13485-compliant Quality Management System (QMS), managing FDA regulatory compliance, overseeing certification and audit activities, and driving quality improvements within medical device manufacturing operations. We need someone that has established

ISO13485

Certification and FDA regulatory compliance from scratch. Job Requirements Bachelor's degree in Engineering, Quality, or a related technical field. Minimum of 10 years of experience in medical device manufacturing quality systems. Direct experience managing and maintaining Quality Management System (QMS) processes. Demonstrated experience implementing ISO 13485 and successfully achieving certification. Hands-on experience completing FDA Establishment Registration and maintaining regulatory compliance. Knowledge of FDA Quality System Regulation (QSR), 21 CFR Part 820, ISO 13485, and applicable global medical device regulations. Experience leading

ISO 13485

certification, surveillance, and recertification audits. Experience managing internal, external, customer, and regulatory quality audits. Knowledge of Corrective and Preventive Action (CAPA), nonconformance management, document control, and supplier quality processes. Understanding of risk management requirements under

ISO 14971.

Experience overseeing manufacturing process validation and quality compliance activities. Experience developing and monitoring quality metrics, audit findings, and regulatory compliance reports. Preferred Skills Experience in injection molding, assembly, machining, or precision medical device manufacturing. American Society for Quality (ASQ) certifications, including Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Certified Manager of Quality/Organizational Excellence (CMQ/OE). Experience using electronic Quality Management Systems (eQMS). Knowledge of global medical device regulatory requirements and notified body audit processes. Experience implementing quality system improvements and manufacturing quality initiatives. Job Responsibilities Lead, maintain, and improve the Quality Management System (QMS) in accordance with

ISO 13485, FDA

requirements, and applicable global regulations. Manage

ISO 13485

certification, surveillance audits, and recertification activities. Oversee FDA Establishment Registration and ongoing regulatory maintenance for manufacturing operations. Serve as the primary contact for regulatory agencies, notified bodies, and customer quality audits. Manage core QMS processes, including document control, CAPA, nonconformance management, supplier quality, internal audits, and training systems. Implement and maintain risk management processes in accordance with

ISO 14971.

Conduct and oversee internal quality system audits to verify compliance with regulatory requirements and established procedures. Manage external audits, regulatory inspections, and customer quality assessments. Investigate quality issues, manufacturing nonconformances, and regulatory compliance concerns. Develop, implement, and monitor corrective and preventive actions to address quality system deficiencies. Ensure manufacturing processes are appropriately validated, controlled, and maintained in accordance with regulatory requirements. Oversee supplier quality activities, including supplier qualification, monitoring, and corrective action processes. Develop and maintain quality documentation, standard operating procedures, work instructions, and compliance records. Establish and monitor quality performance indicators, audit findings, CAPA effectiveness, and regulatory compliance metrics. Prepare and present quality system performance reports, audit results, and compliance status to senior management. Develop and deliver employee training on quality system procedures, regulatory requirements, and compliance standards. Coordinate quality system improvements across Engineering, Manufacturing, Operations, and Regulatory functions. Support continuous improvement initiatives to strengthen manufacturing quality, process controls, and regulatory compliance. Maintain audit readiness and ensure timely resolution of audit findings and regulatory observations. Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #GRP2

Pay:

$110,000.00 - $160,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Military leave Paid time off Parental leave Professional development assistance Retirement plan Tuition reimbursement Vision insurance

Work Location:

In person