Director Quality Assurance & Regulatory Affairs
Based in NJ
Outstanding leadership opportunity with a full-service outsourced manufacturer of Class I, II and III electro-mechanical capital equipment to the medical device industry. Founded in 1999, the Company has a strong track record of growth and an outstanding reputation with its customers based upon its leading technical capabilities, high quality standards, on-time performance and customer service. The Company’s capabilities cover the complete spectrum of the medical device manufacturing product life cycle, from conceptual design and engineering through to manufacturing and after-market service and support. They serve a variety of leading medical device original equipment manufacturers (“OEMs”) with a portfolio of innovative medical devices, and it enjoys high retention rates and revenue visibility over multiple years. With its full suite of design and manufacturing capabilities and focus on all aspects of customer service, the Company positions itself not just as a supplier but as a true value-added partner to its OEM customers. Be a part of this exciting growing Company!
Responsible for directing the development, implementation and maintenance of quality assurance and control systems and activities. Additionally responsible for worldwide regulatory strategy, submissions, and interactions with regulatory bodies. Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating their liability of company products. Responsible for directing, establishing and maintaining QA standards based on internal and external specifications and ensures that the Company has the latest version of industry standards. Develops budgets and monitor expenditures. Enforces corrective action necessary to assure conformity with quality specifications. Assures finished products conform to government and company standards and satisfies GMP regulations. Oversee audits of Quality System and Suppliers and is responsible for Supplier Quality Assurance.
Duties and Responsibilities:
- Responsible for establishing and maintaining the Company’s quality policy and quality objectives and directing all Regulatory Affairs activities.
- Maintain current knowledge of federal and state regulations regarding QSR, ISO, MDD and other quality assurance and regulatory issues.
- Hire, train, and manage Quality Assurance, Control, and Technician Staff. Manage the implementation of quality systems and ensure that all company employees comply with the quality system and process specifications.
- Interface with FDA, ISO and any other external auditors during company inspections.
- Implement changes (CAR) for any findings during all audits.
- Proactively champion quality assurance issues and improvements where applicable in company-wide activities.
- Conduct regular employee training in GMP, ISO 13485 and FDA QS Regulations.
- Conduct regular supplier and contract manufacturer audits.
- Periodically inspect facility to ensure GMP compliance.
- Manage label and document control function per the regulations.
- Ensure that all calibration and maintenance is completed for tools and instruments as needed.
- Maintain databases for product complaints, trending and reportable events.
- Responsible for ensuring all reportable incidents are reported to the applicable regulatory bodies (FDA, Competent Authorities, etc).
- Thoroughly document all issues related to quality assurance, GMP, and ISO compliance.
- Plan schedule, and complete projects in a manner consistent with corporate objectives.
- Proactively communicate project status to management. Procure and oversee outside vendors and consultants as required.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and act as the technical expert for all regulations (FDA, CE, ISO, etc.) ensuring the proper processes, policies and procedures are in place to obtain necessary regulatory approvals and maintain regulatory compliance.
- Determine regulatory strategy for devices/manage regulatory submissions/approvals for all devices.
- Interface with management and manufacturing regarding scheduling, deliverables and expenditures.
- Basic fundamental understanding of assembly drawings, validations, revision control, and theory of operation of electro-mechanical devices.
- 10 years minimum combined QA/RA related experience in the medical device industry with Class I, II and III devices.
- Experience with inspection, calibration and supplier auditing.
- Working knowledge of current FDA Quality System Regulations and ISO 13485 and IEC60601.
- Strong analytical, reasoning, organizational, multitasking and written/oral communication skills.
- Good negotiation, conflict resolution, presentation and facilitation skills.
- Enforces quality policy through investigation of non-conformances, analysis of Customer Complaints and maintenance of an internal audit process.
- BS or MS degree in Electrical Engineering preferred. ASQ QE/CQA desired.
- Ability to create and prepare 510 K submissions is a plus.
Top Reasons to Work Here!
- Growth company with distinct vision and financial resources to execute
- Progressive, small team-based group with stable environment
- Hands-on exposure to customers and an opportunity to have impact in building the business
- Efficient at what they do
- Culture built on meritocracy and recognition for a job well done
Compensation and Benefits
• A competitive compensation package – base salary of $125k-$145k, 25% target performance bonus, healthcare, 401k and vacation and holiday benefits will be offered to the successful candidate.
• Candidates must be authorized to work in the U.S. and be fluent in English.