QMS/Supplier Quality Manager

Astrodyne TDI•Hackettstown, NJ

2d•$125,000 - $140,000•Onsite

About The Position

The Quality Systems (QS)/Supplier Quality Manager is responsible for enterprise-wide quality and regulatory compliance through implementation and maintenance of quality systems and processes. The role owns the Electronic Quality Management System (EQMS) and interrelated quality processes, regulatory agency and audit commitments, corporate training and qualification content, and customer complaints. It collaborates with manufacturing locations and Corporate to ensure documentation and procedural requirements are met, and assures compliance with applicable regulations and standards, including FDA Quality System Regulations (21 CFR 807), AS9100, ISO 9001, and ISO 13485. The position leads development of the quality systems audit program and directly supervises Document Control. The manager establishes and maintains effective supplier and internal audit programs, and leads, conducts, and supports supplier audits. The role works with suppliers to ensure purchased materials meet specifications, obtain root-cause analyses and timely corrective actions for non-conformances, and improve inspection and qualification criteria while maintaining quality. It serves as a liaison among Operations, Engineering, Purchasing, and suppliers to resolve and prevent quality issues. The position is based in Hackettstown, New Jersey, and is 100% onsite, with an average of 20% travel, potentially on short notice. The salary range is $125,000–$140,000 annually, with final compensation based on experience and qualifications. Applicants must be U.S. citizens or permanent residents/Green Card holders; visa sponsorship is not available.

Requirements

Bachelor’s degree (B.S. or B.A.) and at least 5 years’ experience in a related field.
Certified Quality Auditor or ISO Lead Auditor certification qualifying the candidate to conduct Quality System audits against standards and regulations such as 21 CFR 807, AS9001, ISO 9001, and ISO 13485.
Proficiency in Microsoft Office Suite and internet browsers, with experience using an EDMS.
Strong people-management skills, including the ability to train, coach, and motivate direct reports and prioritize effectively.
Strong knowledge of electronic assembly acceptability standards, including IPC 610, 620, SAE, ANSI, or J-STD-001.
Ability to read and interpret electrical schematics and mechanical drawings.
Experience with problem-solving tools such as fishbone diagrams, 5S, 8D, visual factory design, and FMEA.
Ability to thrive in a fast-paced, dynamic environment and build effective relationships with suppliers, peers, and other functional areas.
Strong technical writing skills and ability to explain complex issues concisely and plainly, with familiarity with data analysis.
Ability to communicate with and direct supplier activities at the management level.
Ability to establish and deliver on specific goals and targets.
Ability to travel an average of 20%, potentially on short notice.
Must be a U.S. citizen or permanent resident/Green Card holder; visa sponsorship is unavailable.

Nice To Haves

Bachelor’s degree in Electronics Engineering preferred.
Lead Auditor certification preferred.
Prior experience managing external regulatory audits preferred.

Responsibilities

Manage daily Document Control activities, including work assignments, schedules, document distribution, delegation, coaching, and guidance.
Conduct performance reviews and provide coaching and guidance to direct reports.
Maintain documentation and records in accordance with regulations and internal policies, and manage the periodic review process.
Serve as the point of contact for system inquiries during audits and regulatory inspections; train the organization on system functionality and provide controlled-document copies for internal and external distribution.
Create monthly management reports and metrics for Training, Complaints, and NC/CAPA, and deliver departmental metrics as requested.
Work with direct reports to set individual goals aligned with organizational goals.
Conduct and report external audits of suppliers, laboratories, and third-party manufacturers according to the Supplier Audit Schedule and applicable regulatory and certifying-body standards.
Identify and communicate observed risks to cross-functional and management teams; ensure audit findings are addressed through appropriate CAPAs.
Monitor and report audit effectiveness, including corrective action plans, effectiveness checks, and risks; collaborate on and maintain the Supplier Audit Schedule.
Support development and monitoring of the organization’s Quality Management System, including measurement, analysis, and trending of policy and objective implementation, continuous improvement, training, and management review.
Determine whether findings and audits can be closed or require escalation, and review risk levels with the Director of Quality.
Support site audit readiness and customer and regulatory-body audits.
Assist with writing and reviewing procedures and instructions for Quality Management System development.
Develop and maintain a certification and qualification program for internal auditors.
Interface with Site Audit Leads to evaluate and implement Global Best Practices.
Participate and provide feedback in Management Reviews and other QA-related meetings.
Use sound judgment and critical thinking in Compliance activities.
Participate in the Material Review Board to review and disposition supplier-related non-conforming material as required.
Perform other duties as assigned.