QMS/Supplier Quality Manager

QSM - SUPPLIER QUALITY MANAGER
Hackettstown, New Jersey | 100% Onsite

Position Summary:

Quality Systems (QS)/Supplier Quality Manager is responsible for and has the authority to ensure Enterprise-wide Quality and Regulatory compliance through implementation and maintenance of robust quality systems and processes. This includes but is not limited to System ownership of the Electronic Quality Management System (EQMS), process ownership of interrelated Quality processes, Regulatory Agency and Audit Commitments, contents for Corporate Training and Qualification, and Customer Complaints. This position regularly interacts with other departments and staff groups within the manufacturing locations as well as Corporate to ensure that all documentation and procedural requirements are met. This role assures compliance with global quality systems regulation requirements including, but not limited to, the FDAs Quality System Regulations (21 CFR 807), AS9100, ISO 9001, and ISO 13485. The position provides leadership and development to the audit program for the implementation of quality system. This position provides direct supervision for Document Control.

This position is also responsible for and has the authority to establish and maintain the effectiveness of the supplier audit and internal audit programs. This role will lead, conduct, and support the external supplier audit program as required. This position will also be a key stakeholder in reporting, investigating, and resolving supplier non-conformances both remotely and on-site. This position will work with suppliers to ensure purchased material complies with all specifications and requirements, drive suppliers to provide root cause analysis and timely corrective action of non-conformances, assess inspection and qualification criteria to improve efficiency while maintaining quality. This position acts as a liaison between Operations, Engineering, Purchasing, and suppliers to resolve and prevent quality issues.

Job Responsibilities-

• Manage the daily activities of the Document Control. This includes work assignments, schedule management, document distribution, delegation, coaching, and guidance.
• Conduct performance reviews, coaching, and guidance as appropriate.
• Maintain documentation and records in accordance with regulations and internal policies.
• Manage the periodic review process.

• Point of contact for system inquiries during audits and regulatory inspections.

• Train organization on the functionality of the system.

• Provide copies of controlled documentation for internal and external distribution.

• Create monthly reports and metrics for management review as related to Training, Complaints and NC/CAPA.
• Deliver departmental metrics as requested.
• Work collaboratively with direct reports to establish individual goals to align with organizational goals.
• Conduct and report on external audits of suppliers, labs, and third-party manufacturers in accordance with the Supplier Audit Schedule.
• Audit suppliers, labs, and third-party manufacturers to applicable regulatory and certifying body standards.
• Identify and communicate observed risks to cross-functional and management teams.
• Ensure the audit findings are resolved with appropriate Corrective and Preventive Actions (CAPAs).
• Monitor, and report the effectiveness of audits including corrective action plans, effectiveness checks, and risks.
• Collaborate on and maintain the Supplier Audit Schedule.
• Provide support in the development, and monitoring of the effectiveness of the Quality Management System throughout the organization including measurement, analysis and trending of policy and objectives implementation, identification of continuous improvement opportunities, training, and management review.
• Determine when findings and audits are closed OR require escalation, and risk level review with the Director of Quality.
• Assist in site audit readiness activities and provide support during customer and regulatory body audits.
• Assist with writing and review of procedures and instructions for development of the Quality Management System as required.
• Develop, and maintain a Certification/Qualification program for internal auditors.
• Interface with Site Audit Leads to evaluate and implement Global Best Practices.
• Participates and provides feedback into Management Reviews, and other QA related meetings.
• Consistently demonstrates good judgment and critical thinking in the performance of Compliance activities.

• Participate as a member of the Material Review Board to review and disposition supplier related non-conformance material as required
• All other duties as assigned.

Qualifications:

• B.S or B.A. (Bachelor’s Degree in Electronics Engineering preferred) and 5 + years’ experience in related field.
• Certified Quality Auditor/ISO lead Auditor Certified to conduct Quality System audits against standards and regulations such as 21CFR807, AS9001, ISO 9001, ISO 13485.
• Lead Auditor certification preferred.
• Proficiency in MS Suite, Internet Browsers, experience using EDMS.
• Strong people management skills are required; must be able to train, coach and motivate direct reports to effect a culture of Quality and compliance. Ability to meet needs of Company by effective prioritization.
• Strong knowledge of Electronic Assembly Acceptability - IPC 610, 620, SAE, ANSI, or J-STD-001.
• Exceptional ability to read and interpret electrical schematics and mechanical drawings.
• Experience with problem solving tools (i.e., fishbone diagram, 5S, 8D, visual factory design, FMEA).
• Ability to thrive in a fast paced, dynamic environment. Excellent team building skills in dealing with suppliers, peers, and other functional areas.
• Strong technical writing ability and an ability to explain complex issues in a concise and plain manner familiar with data analysis.
• Ability to communicate and direct supplier activities at the management level
• Ability to set and deliver to specific goals and targets.
• Prior experience managing external regulatory audits preferred.
• An average of 20% travel, possibly on short notice.

SALARY RANGE 

$125,000 - $140,000 annually. Final compensation based on experience and qualifications. 

BENEFITS 

Competitive medical, dental, vision, PTO, 401(k), life and disability insurance, wellness resources, EAP support, and tax-advantaged savings options. 

Due to Military affiliations, we are unable to sponsor candidates who require a Visa. Candidates MUST be a US Citizen or a Permanent Resident/Green Card Holder.

Astrodyne TDI provides equal employment opportunities to all employees and applicants. Our culture is one that provides opportunities for employee involvement, growth, and development. Astrodyne TDI offers competitive salary, paid time off, robust healthcare benefits, and 401(k).