1.0 PURPOSE
· To ensure organizational compliance with applicable regulatory requirements while managing and improving customer-facing quality processes. This position plays a critical role in maintaining product compliance, supporting regulatory submissions, and serving as the main point of contact for all customer quality concerns, complaints, and audits.
2.0 RESPONSIBILITIES/AUTHORITY
· Responsible for the development, maintenance, and oversight of regulatory and compliance programs.
· Contact person to interface directly with regulatory agencies and customers on matters related to compliance and product quality.
· Works with Quality Engineer as main point of contact for customer quality concerns for the purpose of working on, logging and tracking RCA activities.
· Manages and coordinates customer complaint resolution activities across departments assigning the person(s) responsible for root cause analysis (RCA).
· Manages customer audits and ensures timely and accurate follow-up on findings.
· Advises management on changes to regulatory requirements and their impact on products and operations.
· Ensures the company’s quality and environmental policies are implemented and the requirements of their ISO standards and regulations are met.
· Ensures that the company meets the FDA regulations and requirements as a manufacturer of components or medical devices.
· Ensures that regulations of export control compliance (ITAR and EAR) programs are implemented and are being followed.
· Identifies changes to regulations and next certifications the company should pursue to keep the organization at the forefront of customer requirements, or desired compliance.
· Leads or actively participates in continuous improvement initiatives aimed at enhancing operational efficiency, reducing waste, and driving productivity across the organization.
· Fosters and maintains strong, professional relationships with customers, vendors, and regulatory agencies to ensure alignment, trust, and compliance.
· Promotes a culture of continuous improvement by challenging existing processes and behaviors, encouraging innovation, and reinforcing accountability for enterprise-wide quality and performance excellence.
· Responsible for internal audit programs, training internal auditors, scheduling audits, reviewing reports and corrective actions.
3.0 DUTIES
Regulatory Affairs:
· Prepare, submit, and maintain regulatory filings.
· Management representative and monitor of global regulatory trends and ensure ongoing compliance with applicable standards (FDA, ISO 13485, etc.).
· Maintain and create up-to-date regulatory documentation and support internal/external audits and inspections.
· Collaborate and train product development and quality teams to define regulatory strategies for new and existing products.
· Track and report key quality metrics such as PPM, complaint trends, audit findings, and customer satisfaction indicators.
· Coordinate and host customer quality audits and follow through on required actions and documentation.
· Support the negotiation, review, and execution of customer quality agreements.
· Trains, coaches and mentors’ personnel to raise level of understanding of concepts related to regulatory compliance, quality, environmental systems, internal auditing, and good practices in documentation and manufacturing.
Customer Quality Management:
· Serve as the primary contact and coordinator for customer quality issues/complaints.
· Coordinate root cause analysis and implement CAPAs within the enterprise using cross functional teamwork to maintain high customer satisfaction ratings and implement effective corrective actions.
· Ensure that the documentation control process is implemented and followed by the organization.
· Promotes, leads and participates in quality and continuous improvement activities.
· Serves as liaison to external parties in matters related to quality systems and continuous improvement projects.
· Works with personnel at all levels to solve routine and special issues.
4.0 EDUCATION
· Bachelor of Science Degree preferably in Mechanical or Manufacturing Engineering. An Advanced Degree in related discipline a plus.
· Management and Problem-Solving Techniques courses such as: Certifications in Quality, Lean Manufacturing, Six Sigma, Technical Problem Solving or Root Cause Analysis.
· Training in compliance/regulatory programs a plus.
· Certified ISO 13485 Lead Auditor a plus.
5.0 EXPERIENCE
· 10 + years in management level regulatory or quality assurance roles in a manufacturing operation setting with a diverse well-rounded background.
· Minimum of 5 years in Quality administration or engineering role. Experience as Quality Manager and understanding of ISO Quality systems required.
· Knowledge of plastic injection molding processes related to medical devices a plus.
· Strong knowledge of safety procedures and policies a plus.
· Microsoft Office skills required (Excel, Word, PowerPoint, Outlook, etc).
6.0 PERSONAL CHARACTERISTICS
· Highly organized, a positive attitude with attention to detail.
· A highly self-motivated person.
· Willingness to learn and evolve skillsets.
· Excellent written and verbal communication skills.
· Strong interpersonal skills and a team builder.
7.0 REPORTING RELATIONSHIP
· President, Director of Engineering, Director of Operations
Pay: $75,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Professional development assistance
- Tuition reimbursement
- Vision insurance
Work Location: In person
